Diabetes Mellitus, Type 1
Conditions
Keywords
Biomarker, Immune Profile, Biopsy, Leukocyte subsets, Inguinal lymph nodes, Type 1 Diabetes Mellitus
Brief summary
It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes (iLN), which will be distinct from changes observed in peripheral blood derived immune cells. Therefore this study will assess and compare the molecular immune profile of cells derived from the iLN in healthy and NOT1D subjects, to understand the immunological processes that may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15 subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy subjects, to determine if the quality and quantity of cells derived from aspirate or core biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its primary objective. An interim analysis will be carried out after the recruitment of 5 evaluable healthy subjects and 5 evaluable NOT1D subjects. The primary purpose of this interim analysis will be to facilitate decision making and study design for a potential follow-up interventional study.
Interventions
PROCEDUREInguinal lymph node fine needle aspirate biopsy
Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.
PROCEDUREInguinal lymph node core biopsy
Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.
PROCEDUREPeripheral blood collection
Blood sample (30 mL) will be collected, to derive immune cells.
OTHERPre- and post-biopsy questionnaire
All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 40 years of age inclusive, at the time of signing the informed consent. * Healthy subjects will be as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination and laboratory tests. * Subjects will be considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin (HbA1c), International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count are within the normal range at screening. * NOT1D subject with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, with an interval of up to 8 weeks between the initial diagnosis and day 1 of the study (Day 1 = iLN biopsy day). * NOT1D subject, who currently requires insulin treatment for type 1 diabetes (T1D) and has received insulin therapy for at least 7 days prior to screening. * NOT1D subject positive, at screening, for at least one autoantibody associated with T1D: anti- Glutamic Acid Decarboxylase (GAD), anti-Islet antigen 2 (IA-2), anti- islet cell antibodies (ICA), anti-Indole 3 acetic acid (IAA), anti- Zinc transporter 8 (ZnT8). * NOT1D subject with evidence, at screening, of residual functioning beta cells as measured by fasted C-peptide levels \>=0.15 nanomole per liter (nmol/L). * NOT1D subject having values for the following parameters: INR, APTT, platelet count, red blood cells and total lymphocyte count within the normal range at screening. * Both, male or female subjects are eligible to participate in this study. A female subject is only eligible to participate if she is not pregnant \[as confirmed by a negative urine human chorionic gonadotropin (hCG) test\], not lactating at screening and study visit(s) or has documented evidence to not be of child bearing potential. * Capable of giving signed informed consent which includes compliance with the study requirements and study restrictions. * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including Programmed Death 1 (PD-1)+ Inducible Costimulator (ICOS)+ Follicular Helper T (TFH) Cell-like Regulatory (Reg) T Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were planned to be collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Results could not be presented as data were not collected for this analysis due to lack of model convergence or model reliability |
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not availble. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including Reg T Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including Reg T Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. |
| Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. The analysis was based upon Safety Population which comprised of all participants who complete any study assessment. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | Pre Biopsy session on Day 1 | Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates data was not available. |
| Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
| Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). |
| Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Up to Day 14 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. |
| Number of Participants Undergoing Procedure Under Local Anesthetics | Up to Day 4 | Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent procedure under local anesthetics have been presented. |
| Number of Participants Undergoing iLN Biopsy Under Local Anesthetics | Up to Day 4 | Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent iLN biopsy under local anesthetics have been presented. |
| Number of Participants With Different Reasons for Participating in the Study | Up to Day 4 | Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The different reasons have been listed as follows; have friend with diabetes mellitus (DM)/ to progress knowledge, to improve medicines development, participating in the study because of the honorarium, any other reason not listed above was categorized as other and participants having all three reasons as listed above to participate in the study were included in All reasons category |
| Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy | Up to Day 4 | Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants with extreme anxiety towards the procedure have been presented. |
| Number of Participants Looking Forward to Undergo the Procedure | Up to Day 4 | Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants looking forward to undergo the procedure have been presented. |
| Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | Up to Day 4 | Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The aspects better explained were as follows; itself, anesthetic procedure, after-care, none and any other procedure not listed above was categorized as other. |
| Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time | Up to Day 4 | Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who considered to undergo procedure another time have been presented. |
| Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy | Up to Day 4 | Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who were encouraged in study for iLN biopsy have been presented. |
| Number of Participants Who Appreciated Receiving Study Feedback | Up to Day 4 | Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who appreciated receiving study feedback have been presented. |
| Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Biopsy session on Day 1 | Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available. |
Countries
United Kingdom
Participant flow
Recruitment details
This was a multi-center, non-drug treatment study to compare differences in immune cells derived from the inguinal lymph nodes (iLN) and peripheral blood of New Onset Type 1 Diabetes Mellitus (NOT1D) participants and healthy volunteers. Participants were enrolled at a single center in United Kingdom.
Pre-assignment details
Participants underwent iLN biopsies by two methods; fine-needle aspirate (FNA) and core needle biopsy. Participants underwent screening followed by study visits and follow-up. A total of 43 participants were screened, of which, 21 were considered as screen failures and 22 were enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Participants Participants were considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin, International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count were within the normal range at screening. | 12 |
| Participants With NOT1D NOT1D participants with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, were included in the study. | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Healthy Participants | Participants With NOT1D | Total |
|---|---|---|---|
| Age, Continuous | 28.6 Years STANDARD_DEVIATION 5.53 | 27.0 Years STANDARD_DEVIATION 5.35 | 27.9 Years STANDARD_DEVIATION 5.38 |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 9 / 12 | 5 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56bright NK cells; n=9, 10 | 0.54 Percentage of mononuclear cells | Standard Error 0.098 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56lo CD16-; n=8, 9 | 0.19 Percentage of mononuclear cells | Standard Error 0.043 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56+CD16+; n=8, 8 | NA Percentage of mononuclear cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | Dendritic cells; n=9, 10 | 0.45 Percentage of mononuclear cells | Standard Error 0.1 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56lo CD16+; n=9, 10 | 0.68 Percentage of mononuclear cells | Standard Error 0.173 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | NK cells; n=9, 10 | 1.43 Percentage of mononuclear cells | Standard Error 0.324 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | B-cells; n=9, 10 | 8.88 Percentage of mononuclear cells | Standard Error 1.641 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | NK cells; n=9, 10 | 1.50 Percentage of mononuclear cells | Standard Error 0.364 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | B-cells; n=9, 10 | 7.34 Percentage of mononuclear cells | Standard Error 1.512 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56+CD16+; n=8, 8 | NA Percentage of mononuclear cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56bright NK cells; n=9, 10 | 0.50 Percentage of mononuclear cells | Standard Error 0.101 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56lo CD16+; n=9, 10 | 0.69 Percentage of mononuclear cells | Standard Error 0.184 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | CD56lo CD16-; n=8, 9 | 0.21 Percentage of mononuclear cells | Standard Error 0.04 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN | Dendritic cells; n=9, 10 | 0.39 Percentage of mononuclear cells | Standard Error 0.081 |
95% CI: [-3.14, 6.23]
95% CI: [-0.25, 0.34]
95% CI: [-0.54, 0.52]
95% CI: [-0.15, 0.1]
95% CI: [-0.21, 0.34]
95% CI: [-1.1, 0.96]
Primary
Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56bright NK cells | 0.36 Percentage of mononuclear cells | Standard Error 0.042 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56lo CD16- | 0.24 Percentage of mononuclear cells | Standard Error 0.036 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56+CD16+ | NA Percentage of mononuclear cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | Dendritic cells | 0.93 Percentage of mononuclear cells | Standard Error 0.08 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56lo CD16+ | 7.96 Percentage of mononuclear cells | Standard Error 1.011 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | NK cells | 8.71 Percentage of mononuclear cells | Standard Error 0.999 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | B-cells | 8.50 Percentage of mononuclear cells | Standard Error 0.589 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | NK cells | 8.84 Percentage of mononuclear cells | Standard Error 1.095 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | B-cells | 7.58 Percentage of mononuclear cells | Standard Error 0.645 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56+CD16+ | NA Percentage of mononuclear cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56bright NK cells | 0.30 Percentage of mononuclear cells | Standard Error 0.046 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56lo CD16+ | 8.24 Percentage of mononuclear cells | Standard Error 1.108 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | CD56lo CD16- | 0.23 Percentage of mononuclear cells | Standard Error 0.04 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood | Dendritic cells | 0.87 Percentage of mononuclear cells | Standard Error 0.088 |
95% CI: [-0.9, 2.75]
95% CI: [-0.07, 0.19]
95% CI: [-3.41, 2.84]
95% CI: [-0.1, 0.13]
95% CI: [-0.19, 0.31]
95% CI: [-3.23, 2.96]
Primary
Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. The analysis was based upon Safety Population which comprised of all participants who complete any study assessment. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Circulating B Lymphocytes; n=12, 10 | 16.54 Percentage of B lymphocytes | Standard Error 2.229 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Classical B Lymphocytes; n=12, 10 | 19.37 Percentage of B lymphocytes | Standard Error 1.616 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Double Negative B Lymphocytes; n=12, 10 | 3.25 Percentage of B lymphocytes | Standard Error 1.25 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Naive B Lymphocytes; n=12, 10 | 59.81 Percentage of B lymphocytes | Standard Error 3.021 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Plasmablast ; n=11, 10 | NA Percentage of B lymphocytes | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Transitional B Lymphocytes; n=12, 10 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Plasmablast ; n=11, 10 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Circulating B Lymphocytes; n=12, 10 | 14.23 Percentage of B lymphocytes | Standard Error 2.442 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Naive B Lymphocytes; n=12, 10 | 62.32 Percentage of B lymphocytes | Standard Error 3.31 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Classical B Lymphocytes; n=12, 10 | 15.83 Percentage of B lymphocytes | Standard Error 1.771 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Transitional B Lymphocytes; n=12, 10 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood | Double Negative B Lymphocytes; n=12, 10 | 6.26 Percentage of B lymphocytes | Standard Error 1.37 |
95% CI: [-4.59, 9.21]
95% CI: [-1.46, 8.54]
95% CI: [-6.87, 0.86]
95% CI: [-11.86, 6.84]
Primary
Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Classical B Lymphocytes; n=9, 10 | 38.78 Percentage of B lymphocytes | Standard Error 4.119 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Circulating B Lymphocytes; n=9, 10 | 15.51 Percentage of B lymphocytes | Standard Error 1.86 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Double Negative B Lymphocytes; n=9, 10 | 8.68 Percentage of B lymphocytes | Standard Error 1.668 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Naive B Lymphocytes; n=9, 10 | 35.83 Percentage of B lymphocytes | Standard Error 3.761 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Plasmablast; n=4, 8 | NA Percentage of B lymphocytes | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Transitional B Lymphocytes; ; n=3, 2 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Plasmablast; n=4, 8 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Naive B Lymphocytes; n=9, 10 | 44.13 Percentage of B lymphocytes | Standard Error 3.621 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Circulating B Lymphocytes; n=9, 10 | 12.14 Percentage of B lymphocytes | Standard Error 1.898 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Classical B Lymphocytes; n=9, 10 | 30.19 Percentage of B lymphocytes | Standard Error 4.13 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Transitional B Lymphocytes; ; n=3, 2 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN | Double Negative B Lymphocytes; n=9, 10 | 10.26 Percentage of B lymphocytes | Standard Error 1.651 |
95% CI: [-2.22, 8.98]
95% CI: [-3.72, 20.91]
95% CI: [-6.53, 3.38]
95% CI: [-19.32, 2.71]
Primary
Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood | CD14+ CD16+ monocytes | NA Percentage of monocytes |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood | CD14+ monocytes | NA Percentage of monocytes |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood | CD16+ monocytes | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood | CD14+ CD16+ monocytes | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood | CD14+ monocytes | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood | CD16+ monocytes | NA Percentage of monocytes |
Primary
Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN | CD14+ monocytes; n=7, 4 | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN | CD14+ CD16+ monocytes; n=0, 1 | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN | CD14+ monocytes; n=7, 4 | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN | CD16+ monocytes; n=0, 2 | NA Percentage of monocytes |
Primary
Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | CD15s+ Conv T cells | 2.59 Percentage of total Conv T cells | Standard Error 0.405 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | CD69+ Conv T cells | 2.05 Percentage of total Conv T cells | Standard Error 0.206 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | Helios+ Conv T cells | 2.07 Percentage of total Conv T cells | Standard Error 0.233 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | Ki67+ Conv T cells | 1.02 Percentage of total Conv T cells | Standard Error 0.202 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | Ki67+ Conv T cells | 1.18 Percentage of total Conv T cells | Standard Error 0.221 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | CD15s+ Conv T cells | 2.28 Percentage of total Conv T cells | Standard Error 0.444 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | Helios+ Conv T cells | 1.68 Percentage of total Conv T cells | Standard Error 0.255 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood | CD69+ Conv T cells | 1.41 Percentage of total Conv T cells | Standard Error 0.226 |
95% CI: [-0.94, 1.57]
95% CI: [0, 1.28]
95% CI: [-0.33, 1.11]
95% CI: [-0.78, 0.47]
Primary
Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | CD15s+ Conv T cells; n=11, 8 | 4.43 Percentage of total Conv T cells | Standard Error 0.653 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | Ki67+ Conv T cells; n= 11,8 | 4.39 Percentage of total Conv T cells | Standard Error 0.56 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | CD69+ Conv T cells; n=11, 9 | 27.74 Percentage of total Conv T cells | Standard Error 3.06 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | Helios+ Conv T cells;n=11,9 | 5.50 Percentage of total Conv T cells | Standard Error 0.631 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | Ki67+ Conv T cells; n= 11,8 | 1.65 Percentage of total Conv T cells | Standard Error 0.669 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | Helios+ Conv T cells;n=11,9 | 5.35 Percentage of total Conv T cells | Standard Error 0.72 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | CD69+ Conv T cells; n=11, 9 | 30.29 Percentage of total Conv T cells | Standard Error 3.589 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN | CD15s+ Conv T cells; n=11, 8 | 2.65 Percentage of total Conv T cells | Standard Error 0.743 |
95% CI: [-0.3, 3.86]
95% CI: [-12.45, 7.35]
95% CI: [-1.86, 2.14]
95% CI: [0.9, 4.58]
Primary
Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | CD15s+ Memory Conv T cells | 5.39 Percentage of total memory Conv T cells | Standard Error 0.906 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | CD69+ Memory Conv T cells | 2.53 Percentage of total memory Conv T cells | Standard Error 0.237 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | Helios+ Memory Conv T cells | 3.46 Percentage of total memory Conv T cells | Standard Error 0.401 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | Ki67+ Memory Conv T cells | 2.03 Percentage of total memory Conv T cells | Standard Error 0.397 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | CD69+ Memory Conv T cells | 1.69 Percentage of total memory Conv T cells | Standard Error 0.259 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | CD15s+ Memory Conv T cells | 4.82 Percentage of total memory Conv T cells | Standard Error 0.993 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | Ki67+ Memory Conv T cells | 2.34 Percentage of total memory Conv T cells | Standard Error 0.435 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood | Helios+ Memory Conv T cells | 2.64 Percentage of total memory Conv T cells | Standard Error 0.439 |
95% CI: [-2.23, 3.38]
95% CI: [0.1, 1.57]
95% CI: [-0.41, 2.07]
95% CI: [-1.54, 0.92]
Primary
Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | CD15s+ Memory Conv T cells; n=11, 8 | 7.60 Percentage of total memory Conv T cells | Standard Error 1.131 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | CD69+ Memory Conv T cells; n=11, 9 | 44.32 Percentage of total memory Conv T cells | Standard Error 2.739 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | Helios+ Memory Conv T cells; n= 11, 9 | 8.25 Percentage of total memory Conv T cells | Standard Error 1.45 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | Ki67+ Memory Conv T cells; n=11,8 | 4.47 Percentage of total memory Conv T cells | Standard Error 0.545 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | Ki67+ Memory Conv T cells; n=11,8 | 2.33 Percentage of total memory Conv T cells | Standard Error 0.643 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | CD15s+ Memory Conv T cells; n=11, 8 | 4.59 Percentage of total memory Conv T cells | Standard Error 1.307 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | Helios+ Memory Conv T cells; n= 11, 9 | 6.97 Percentage of total memory Conv T cells | Standard Error 1.438 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN | CD69+ Memory Conv T cells; n=11, 9 | 46.38 Percentage of total memory Conv T cells | Standard Error 3.433 |
95% CI: [-0.62, 6.63]
95% CI: [-11.33, 7.21]
95% CI: [-14.56, 17.13]
95% CI: [0.36, 3.92]
Primary
Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | CD15s+ Reg T cells; n= 12, 10 | 7.84 Percentage of T Reg cells | Standard Error 1.492 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | CD69+ Reg T cells; n= 11, 10 | 3.19 Percentage of T Reg cells | Standard Error 0.213 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Helios+ Reg T cells; n= 12, 10 | 75.19 Percentage of T Reg cells | Standard Error 2.034 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Ki67+ T Reg cells; n= 12, 10 | 5.34 Percentage of T Reg cells | Standard Error 0.664 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Memory Reg T cells; n= 12, 10 | 40.93 Percentage of T Reg cells | Standard Error 2.563 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Resting Reg T cells n= 12, 10 | 45.34 Percentage of T Reg cells | Standard Error 3.191 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Memory Reg T cells; n= 12, 10 | 45.79 Percentage of T Reg cells | Standard Error 2.808 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | CD15s+ Reg T cells; n= 12, 10 | 9.13 Percentage of T Reg cells | Standard Error 1.635 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Ki67+ T Reg cells; n= 12, 10 | 6.32 Percentage of T Reg cells | Standard Error 0.727 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | CD69+ Reg T cells; n= 11, 10 | 2.27 Percentage of T Reg cells | Standard Error 0.223 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Resting Reg T cells n= 12, 10 | 36.74 Percentage of T Reg cells | Standard Error 3.496 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood | Helios+ Reg T cells; n= 12, 10 | 70.98 Percentage of T Reg cells | Standard Error 2.228 |
95% CI: [-5.91, 3.32]
95% CI: [0.28, 1.57]
95% CI: [-2.08, 10.51]
95% CI: [-3.03, 1.08]
95% CI: [-12.8, 3.07]
95% CI: [-1.27, 18.47]
Primary
Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | CD15s+ Reg T cells; n=11, 8 | 16.54 Percentage of T Reg cells | Standard Error 3.248 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | CD69+ Reg T cells; n= 11, 9 | 48.02 Percentage of T Reg cells | Standard Error 3.034 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Helios+ Reg T cells; n=11,9 | 81.28 Percentage of T Reg cells | Standard Error 1.723 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Ki67+ T Reg cell; n= 10, 8 | 8.39 Percentage of T Reg cells | Standard Error 1.347 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Memory Reg T cells; n= 11, 9 | 50.12 Percentage of T Reg cells | Standard Error 2.66 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Resting Reg T cells; n=11,9 | 35.32 Percentage of T Reg cells | Standard Error 3.031 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Memory Reg T cells; n= 11, 9 | 49.90 Percentage of T Reg cells | Standard Error 3.022 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Resting Reg T cells; n=11,9 | 27.00 Percentage of T Reg cells | Standard Error 3.453 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | CD15s+ Reg T cells; n=11, 8 | 10.01 Percentage of T Reg cells | Standard Error 3.675 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Helios+ Reg T cells; n=11,9 | 79.17 Percentage of T Reg cells | Standard Error 1.837 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | CD69+ Reg T cells; n= 11, 9 | 56.55 Percentage of T Reg cells | Standard Error 3.451 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN | Ki67+ T Reg cell; n= 10, 8 | 5.09 Percentage of T Reg cells | Standard Error 1.505 |
95% CI: [-3.78, 16.85]
95% CI: [-18.17, 1.1]
95% CI: [-3.23, 7.45]
95% CI: [-0.98, 7.59]
95% CI: [-8.23, 8.67]
95% CI: [-1.32, 17.95]
Primary
Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Central Memory CD8 | 7.13 Percentage of CD8 T cells | Standard Error 1.537 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Naive CD8 | 34.38 Percentage of CD8 T cells | Standard Error 3.863 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Effector Memory CD8 | 19.22 Percentage of CD8 T cells | Standard Error 2.223 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Stem Cell Memory-like CD8 | 1.34 Percentage of CD8 T cells | Standard Error 0.206 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | CD45RA+ Effector Memory CD8 | 29.89 Percentage of CD8 T cells | Standard Error 4.267 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Stem Cell Memory-like CD8 | 1.37 Percentage of CD8 T cells | Standard Error 0.225 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | CD45RA+ Effector Memory CD8 | 28.10 Percentage of CD8 T cells | Standard Error 4.674 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Central Memory CD8 | 6.98 Percentage of CD8 T cells | Standard Error 1.684 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Effector Memory CD8 | 14.84 Percentage of CD8 T cells | Standard Error 2.435 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood | Naive CD8 | 40.44 Percentage of CD8 T cells | Standard Error 4.231 |
95% CI: [-11.41, 14.99]
95% CI: [-4.6, 4.91]
95% CI: [-2.5, 11.26]
95% CI: [-18.01, 5.89]
95% CI: [-0.67, 0.6]
Primary
Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Central Memory CD8 | 5.55 Percentage of CD8 T cells | Standard Error 0.978 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Naive CD8 | 55.12 Percentage of CD8 T cells | Standard Error 4.259 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Effector Memory CD8 | 13.74 Percentage of CD8 T cells | Standard Error 1.867 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Stem Cell Memory-like CD8 | 1.69 Percentage of CD8 T cells | Standard Error 0.316 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | CD45RA+ Effector Memory CD8 | 14.54 Percentage of CD8 T cells | Standard Error 2.094 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Stem Cell Memory-like CD8 | 2.36 Percentage of CD8 T cells | Standard Error 0.377 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | CD45RA+ Effector Memory CD8 | 13.34 Percentage of CD8 T cells | Standard Error 2.33 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Central Memory CD8 | 6.21 Percentage of CD8 T cells | Standard Error 1.093 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Effector Memory CD8 | 15.59 Percentage of CD8 T cells | Standard Error 2.074 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN | Naive CD8 | 54.45 Percentage of CD8 T cells | Standard Error 4.7 |
95% CI: [-5.33, 7.73]
95% CI: [-3.73, 2.41]
95% CI: [-7.67, 3.96]
95% CI: [-12.54, 13.87]
95% CI: [-1.71, 0.36]
Primary
Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56+CD16+ | NA Percentage of NK cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56bright NK cells | 5.02 Percentage of NK cells | Standard Error 0.894 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56lo CD16+ | 89.71 Percentage of NK cells | Standard Error 1.567 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56lo CD16- | 3.11 Percentage of NK cells | Standard Error 0.497 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56lo CD16- | 2.70 Percentage of NK cells | Standard Error 0.545 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56+CD16+ | NA Percentage of NK cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56lo CD16+ | 92.40 Percentage of NK cells | Standard Error 1.717 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood | CD56bright NK cells | 3.99 Percentage of NK cells | Standard Error 0.98 |
95% CI: [-1.73, 3.8]
95% CI: [-7.54, 2.16]
95% CI: [-1.12, 1.95]
Primary
Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56+CD16+; n=8, 8 | NA Percentage of NK cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56bright NK cells; n=9, 10 | 41.85 Percentage of NK cells | Standard Error 3.999 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56lo CD16+; n=9, 10 | 37.12 Percentage of NK cells | Standard Error 6.22 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56lo CD16-; n=8, 9 | 12.80 Percentage of NK cells | Standard Error 1.855 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56lo CD16-; n=8, 9 | 14.26 Percentage of NK cells | Standard Error 1.49 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56+CD16+; n=8, 8 | NA Percentage of NK cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56lo CD16+; n=9, 10 | 45.01 Percentage of NK cells | Standard Error 4.9 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN | CD56bright NK cells; n=9, 10 | 35.01 Percentage of NK cells | Standard Error 3.868 |
95% CI: [-4.92, 18.6]
95% CI: [-24.77, 9]
95% CI: [-6.66, 3.73]
Primary
Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood | CD69+ CD8 cells | 3.23 Percentage of CD8 T cells | Standard Error 0.299 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood | Ki67+ CD8 cells | 1.06 Percentage of CD8 T cells | Standard Error 0.391 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood | CD69+ CD8 cells | 2.28 Percentage of CD8 T cells | Standard Error 0.327 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood | Ki67+ CD8 cells | 1.89 Percentage of CD8 T cells | Standard Error 0.429 |
95% CI: [0.02, 1.87]
95% CI: [-2.04, 0.38]
Primary
Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN | CD69+ CD8 cells; n=11, 9 | 17.77 Percentage of CD8 T cells | Standard Error 2.95 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN | Ki67+ CD8 cells; n= 11, 6 | 5.86 Percentage of CD8 T cells | Standard Error 0.646 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN | CD69+ CD8 cells; n=11, 9 | 20.54 Percentage of CD8 T cells | Standard Error 3.127 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN | Ki67+ CD8 cells; n= 11, 6 | 3.66 Percentage of CD8 T cells | Standard Error 0.828 |
95% CI: [-11.81, 6.27]
95% CI: [-0.04, 4.44]
Primary
Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Central Memory Conv T cells | 32.21 Percentage of total Conv T cells | Standard Error 2.125 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Naive Conv T cells | 43.40 Percentage of total Conv T cells | Standard Error 2.586 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | CD45RA+ Effector Memory Conv T cells | 2.47 Percentage of total Conv T cells | Standard Error 0.856 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Stem Cell Memory-like Conv T cells | 0.91 Percentage of total Conv T cells | Standard Error 0.098 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Effector Memory Conv T cells | 11.74 Percentage of total Conv T cells | Standard Error 1.409 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Stem Cell Memory-like Conv T cells | 1.01 Percentage of total Conv T cells | Standard Error 0.107 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Central Memory Conv T cells | 33.75 Percentage of total Conv T cells | Standard Error 2.328 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Effector Memory Conv T cells | 11.97 Percentage of total Conv T cells | Standard Error 1.543 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | Naive Conv T cells | 42.48 Percentage of total Conv T cells | Standard Error 2.833 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood | CD45RA+ Effector Memory Conv T cells | 1.44 Percentage of total Conv T cells | Standard Error 0.937 |
95% CI: [-1.61, 3.68]
95% CI: [-8.12, 5.03]
95% CI: [-4.59, 4.13]
95% CI: [-7.08, 8.92]
95% CI: [-0.4, 0.21]
Primary
Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Central Memory Conv T cells | 23.07 Percentage of total Conv T cells | Standard Error 2.646 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Naive Conv T cells | 46.13 Percentage of total Conv T cells | Standard Error 3.081 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Effector Memory Conv T cells | 20.43 Percentage of total Conv T cells | Standard Error 2.422 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Stem Cell Memory-like Conv T cells | 1.35 Percentage of total Conv T cells | Standard Error 0.176 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | CD45RA+ Effector Memory Conv T cells | 1.14 Percentage of total Conv T cells | Standard Error 0.152 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Stem Cell Memory-like Conv T cells | 1.57 Percentage of total Conv T cells | Standard Error 0.201 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | CD45RA+ Effector Memory Conv T cells | 0.88 Percentage of total Conv T cells | Standard Error 0.18 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Central Memory Conv T cells | 25.03 Percentage of total Conv T cells | Standard Error 2.923 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Effector Memory Conv T cells | 18.28 Percentage of total Conv T cells | Standard Error 2.692 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN | Naive Conv T cells | 46.93 Percentage of total Conv T cells | Standard Error 3.454 |
95% CI: [-0.77, 0.34]
95% CI: [-0.23, 0.75]
95% CI: [-10.2, 6.29]
95% CI: [-5.38, 9.69]
95% CI: [-10.47, 8.86]
Primary
Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood | Myeloid Dendritic cells | 51.78 Percentage of total dendritic cells | Standard Error 3.073 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood | Plasmacytoid Dendritic cells | 45.51 Percentage of total dendritic cells | Standard Error 3.14 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood | Myeloid Dendritic cells | 50.45 Percentage of total dendritic cells | Standard Error 3.366 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood | Plasmacytoid Dendritic cells | 47.36 Percentage of total dendritic cells | Standard Error 3.44 |
95% CI: [-8.17, 10.84]
95% CI: [-11.57, 7.86]
Primary
Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN | Myeloid Dendritic cells; n=8, 10 | 42.96 Percentage of total dendritic cells | Standard Error 3.87 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN | Plasmacytoid Dendritic cells; n=9, 9 | 57.43 Percentage of total dendritic cells | Standard Error 4.426 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN | Myeloid Dendritic cells; n=8, 10 | 30.72 Percentage of total dendritic cells | Standard Error 4.128 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN | Plasmacytoid Dendritic cells; n=9, 9 | 68.30 Percentage of total dendritic cells | Standard Error 5.372 |
95% CI: [0.38, 24.09]
95% CI: [-25.52, 3.78]
Primary
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN | NA Percentage of TFH cell-like Reg T cells |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN | NA Percentage of TFH cell-like Reg T cells |
Primary
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood | 0.53 Percentage of TFH cells | Standard Error 0.173 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood | 0.87 Percentage of TFH cells | Standard Error 0.16 |
95% CI: [-0.84, 0.16]
Primary
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Population: Safety Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN | 2.75 Percentage of TFH cells | Standard Error 3.192 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN | 8.96 Percentage of TFH cells | Standard Error 2.973 |
95% CI: [-15.37, 2.96]
Primary
Percentage of Leukocyte Subsets Including Programmed Death 1 (PD-1)+ Inducible Costimulator (ICOS)+ Follicular Helper T (TFH) Cell-like Regulatory (Reg) T Cells in Blood
Peripheral blood samples were planned to be collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Results could not be presented as data were not collected for this analysis due to lack of model convergence or model reliability
Time frame: Pre Biopsy session on Day 1
Population: Safety Population. Data were not collected due to lack of model convergence or model reliability.
Primary
Percentage of Leukocyte Subsets Including Reg T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Reg T Cells in Blood | 6.95 Percentage of CD4 T cells | Standard Error 0.405 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Reg T Cells in Blood | 6.56 Percentage of CD4 T cells | Standard Error 0.444 |
95% CI: [-0.86, 1.65]
Primary
Percentage of Leukocyte Subsets Including Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.
Time frame: Biopsy session on Day 1
Population: Safety Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Reg T Cells in iLN | 12.04 Percentage of CD4 T cells | Standard Error 0.631 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Reg T Cells in iLN | 12.28 Percentage of CD4 T cells | Standard Error 0.682 |
95% CI: [-2.18, 1.7]
Primary
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not availble. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 TH17-like Reg T cells; n=7, 7 | NA Percentage of total memory Reg T cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH17 cells-like Reg T cells; n=12, 10 | 17.37 Percentage of total memory Reg T cells | Standard Error 0.869 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH2 cells-like Reg T cells; n=12, 10 | 12.47 Percentage of total memory Reg T cells | Standard Error 1.285 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH22 cells-like Reg T cells; n=12, 10 | 11.46 Percentage of total memory Reg T cells | Standard Error 0.953 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TFH cells-like Reg T cells; n=12, 10 | 11.63 Percentage of total memory Reg T cells | Standard Error 1.901 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 cells-like Reg T cells; n=12, 10 | 5.35 Percentage of total memory Reg T cells | Standard Error 0.643 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 TH17 TH2 cells-like Reg T cells; n=12, 10 | 10.48 Percentage of total memory Reg T cells | Standard Error 1.036 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 TH2 cells-like Reg T cells; n=12, 10 | 12.04 Percentage of total memory Reg T cells | Standard Error 0.649 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH17 cells-like Reg T cells; n=12, 10 | 17.67 Percentage of total memory Reg T cells | Standard Error 0.952 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 cells-like Reg T cells; n=12, 10 | 6.18 Percentage of total memory Reg T cells | Standard Error 0.704 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 TH17-like Reg T cells; n=7, 7 | NA Percentage of total memory Reg T cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH2 cells-like Reg T cells; n=12, 10 | 9.09 Percentage of total memory Reg T cells | Standard Error 1.408 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 TH2 cells-like Reg T cells; n=12, 10 | 10.24 Percentage of total memory Reg T cells | Standard Error 0.711 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH22 cells-like Reg T cells; n=12, 10 | 12.63 Percentage of total memory Reg T cells | Standard Error 1.044 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TH1 TH17 TH2 cells-like Reg T cells; n=12, 10 | 13.36 Percentage of total memory Reg T cells | Standard Error 1.135 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood | TFH cells-like Reg T cells; n=12, 10 | 16.46 Percentage of total memory Reg T cells | Standard Error 2.083 |
95% CI: [-10.71, 1.05]
95% CI: [-2.82, 1.16]
95% CI: [-6.08, 0.33]
95% CI: [-0.2, 3.81]
95% CI: [-2.99, 2.39]
95% CI: [-0.59, 7.36]
95% CI: [-4.11, 1.78]
Primary
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | PD-1+ ICOS+ TFH cells-like Reg T cells; n=5,7 | NA Percentage of total memory Reg T cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 TH2 cells-like Reg T cells; n=12, 10 | 10.12 Percentage of total memory Reg T cells | Standard Error 1.085 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 TH17-like Reg T cells; n=1, 2 | NA Percentage of total memory Reg T cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 cells-like Reg T cells; n=12, 10 | 7.31 Percentage of total memory Reg T cells | Standard Error 1.202 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH2 cells-like Reg T cells; n=12, 10 | 27.83 Percentage of total memory Reg T cells | Standard Error 2.262 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH22 cells-like Reg T cells; n=8, 7 | 2.29 Percentage of total memory Reg T cells | Standard Error 0.513 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH17 cells-like Reg T cells; n=12, 10 | 7.20 Percentage of total memory Reg T cells | Standard Error 1.418 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 TH17 TH2 cells-like Reg T cells; n=7, 6 | 2.56 Percentage of total memory Reg T cells | Standard Error 0.839 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TFH cells-like Reg T cells; n=12, 10 | 13.48 Percentage of total memory Reg T cells | Standard Error 1.913 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH22 cells-like Reg T cells; n=8, 7 | 2.70 Percentage of total memory Reg T cells | Standard Error 0.628 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TFH cells-like Reg T cells; n=12, 10 | 12.97 Percentage of total memory Reg T cells | Standard Error 2.203 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | PD-1+ ICOS+ TFH cells-like Reg T cells; n=5,7 | NA Percentage of total memory Reg T cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 cells-like Reg T cells; n=12, 10 | 11.41 Percentage of total memory Reg T cells | Standard Error 1.395 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 TH17-like Reg T cells; n=1, 2 | NA Percentage of total memory Reg T cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 TH17 TH2 cells-like Reg T cells; n=7, 6 | 4.11 Percentage of total memory Reg T cells | Standard Error 0.871 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH1 TH2 cells-like Reg T cells; n=12, 10 | 10.99 Percentage of total memory Reg T cells | Standard Error 1.342 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH17 cells-like Reg T cells; n=12, 10 | 7.67 Percentage of total memory Reg T cells | Standard Error 1.673 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN | TH2 cells-like Reg T cells; n=12, 10 | 27.24 Percentage of total memory Reg T cells | Standard Error 2.546 |
95% CI: [-5.6, 6.63]
95% CI: [-7.93, -0.26]
95% CI: [-4.34, 1.24]
95% CI: [-4.51, 2.77]
95% CI: [-5.02, 4.09]
95% CI: [-6.52, 7.68]
95% CI: [-2.21, 1.4]
Primary
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood
Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Pre Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | PD-1+ ICOS+ TFH cells; n=6, 7 | 0.13 Percentage of total memory Conv T cells | Standard Error 0.036 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 TH17 TH2 T cells; n=12, 10 | 7.16 Percentage of total memory Conv T cells | Standard Error 0.75 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 cells; n=12, 10 | 19.69 Percentage of total memory Conv T cells | Standard Error 2.895 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 TH2 cells; n=12, 10 | 9.30 Percentage of total memory Conv T cells | Standard Error 0.692 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH17 cells; n=12, 10 | 7.79 Percentage of total memory Conv T cells | Standard Error 0.963 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH2 cells; n=12, 10 | 8.46 Percentage of total memory Conv T cells | Standard Error 0.994 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 TH17 cells; n=12, 10 | 16.25 Percentage of total memory Conv T cells | Standard Error 1.606 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH22 cells; n=12, 10 | 3.00 Percentage of total memory Conv T cells | Standard Error 0.34 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TFH cells; n=12, 10 | 16.77 Percentage of total memory Conv T cells | Standard Error 1.723 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH22 cells; n=12, 10 | 3.01 Percentage of total memory Conv T cells | Standard Error 0.372 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TFH cells; n=12, 10 | 21.86 Percentage of total memory Conv T cells | Standard Error 1.888 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | PD-1+ ICOS+ TFH cells; n=6, 7 | 0.18 Percentage of total memory Conv T cells | Standard Error 0.035 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH17 cells; n=12, 10 | 7.89 Percentage of total memory Conv T cells | Standard Error 1.055 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 cells; n=12, 10 | 17.60 Percentage of total memory Conv T cells | Standard Error 3.172 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 TH17 cells; n=12, 10 | 16.22 Percentage of total memory Conv T cells | Standard Error 1.759 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 TH17 TH2 T cells; n=12, 10 | 7.16 Percentage of total memory Conv T cells | Standard Error 0.821 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH1 TH2 cells; n=12, 10 | 9.90 Percentage of total memory Conv T cells | Standard Error 0.758 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood | TH2 cells; n=12, 10 | 6.89 Percentage of total memory Conv T cells | Standard Error 1.089 |
95% CI: [-6.87, 11.05]
95% CI: [-10.42, 0.25]
95% CI: [-0.15, 0.07]
95% CI: [-3.08, 2.88]
95% CI: [-4.94, 5]
95% CI: [-2.31, 2.32]
95% CI: [-2.73, 1.55]
95% CI: [-1.51, 4.64]
95% CI: [-1.05, 1.05]
Primary
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | PD-1+ ICOS+ TFH cells; n=10,10 | 1.30 Percenatge of total memory Conv T cells | Standard Error 0.662 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 TH17 TH2 T cells; n=11,10 | 1.94 Percenatge of total memory Conv T cells | Standard Error 0.36 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 cells; n=12,10 | 15.08 Percenatge of total memory Conv T cells | Standard Error 1.878 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 TH2 cells; n=12,10 | 7.73 Percenatge of total memory Conv T cells | Standard Error 0.816 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH17 cells; n=12,10 | 6.56 Percenatge of total memory Conv T cells | Standard Error 0.932 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH2 cells; n=12,10 | 20.03 Percenatge of total memory Conv T cells | Standard Error 1.754 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 TH17 cells; n=11,10 | 3.03 Percenatge of total memory Conv T cells | Standard Error 0.483 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH22 cells; n=12,10 | 1.50 Percenatge of total memory Conv T cells | Standard Error 0.277 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TFH cells; n=12,10 | 23.02 Percenatge of total memory Conv T cells | Standard Error 2.385 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH22 cells; n=12,10 | 1.48 Percenatge of total memory Conv T cells | Standard Error 0.352 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TFH cells; n=12,10 | 21.48 Percenatge of total memory Conv T cells | Standard Error 2.706 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | PD-1+ ICOS+ TFH cells; n=10,10 | 1.93 Percenatge of total memory Conv T cells | Standard Error 0.542 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH17 cells; n=12,10 | 6.15 Percenatge of total memory Conv T cells | Standard Error 1.033 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 cells; n=12,10 | 18.58 Percenatge of total memory Conv T cells | Standard Error 2.11 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 TH17 cells; n=11,10 | 2.78 Percenatge of total memory Conv T cells | Standard Error 0.558 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 TH17 TH2 T cells; n=11,10 | 1.54 Percenatge of total memory Conv T cells | Standard Error 0.409 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH1 TH2 cells; n=12,10 | 7.25 Percenatge of total memory Conv T cells | Standard Error 0.942 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN | TH2 cells; n=12,10 | 16.98 Percenatge of total memory Conv T cells | Standard Error 1.975 |
95% CI: [-5.99, 9.07]
95% CI: [-2.43, 1.18]
95% CI: [-2.49, 3.31]
95% CI: [-9.39, 2.39]
95% CI: [-1.29, 1.78]
95% CI: [-0.73, 1.54]
95% CI: [-2.12, 3.07]
95% CI: [-2.45, 8.55]
95% CI: [-0.92, 0.96]
Secondary
Number of Participants Looking Forward to Undergo the Procedure
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants looking forward to undergo the procedure have been presented.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants Looking Forward to Undergo the Procedure | 1 Participants |
| Participants With NOT1D | Number of Participants Looking Forward to Undergo the Procedure | 0 Participants |
Secondary
Number of Participants Undergoing iLN Biopsy Under Local Anesthetics
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent iLN biopsy under local anesthetics have been presented.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants Undergoing iLN Biopsy Under Local Anesthetics | 0 Participants |
| Participants With NOT1D | Number of Participants Undergoing iLN Biopsy Under Local Anesthetics | 0 Participants |
Secondary
Number of Participants Undergoing Procedure Under Local Anesthetics
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent procedure under local anesthetics have been presented.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants Undergoing Procedure Under Local Anesthetics | 6 Participants |
| Participants With NOT1D | Number of Participants Undergoing Procedure Under Local Anesthetics | 7 Participants |
Secondary
Number of Participants Who Appreciated Receiving Study Feedback
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who appreciated receiving study feedback have been presented.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants Who Appreciated Receiving Study Feedback | 12 Participants |
| Participants With NOT1D | Number of Participants Who Appreciated Receiving Study Feedback | 10 Participants |
Secondary
Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who considered to undergo procedure another time have been presented.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time | 10 Participants |
| Participants With NOT1D | Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time | 9 Participants |
Secondary
Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who were encouraged in study for iLN biopsy have been presented.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy | 11 Participants |
| Participants With NOT1D | Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy | 8 Participants |
Secondary
Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure
Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The aspects better explained were as follows; itself, anesthetic procedure, after-care, none and any other procedure not listed above was categorized as other.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Participants | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | Anesthetic procedure | 0 Participants |
| Healthy Participants | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | None | 9 Participants |
| Healthy Participants | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | After-care | 1 Participants |
| Healthy Participants | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | Other | 1 Participants |
| Healthy Participants | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | Procedure itself | 1 Participants |
| Participants With NOT1D | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | Other | 0 Participants |
| Participants With NOT1D | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | Procedure itself | 1 Participants |
| Participants With NOT1D | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | Anesthetic procedure | 0 Participants |
| Participants With NOT1D | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | After-care | 0 Participants |
| Participants With NOT1D | Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure | None | 9 Participants |
Secondary
Number of Participants With Different Reasons for Participating in the Study
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The different reasons have been listed as follows; have friend with diabetes mellitus (DM)/ to progress knowledge, to improve medicines development, participating in the study because of the honorarium, any other reason not listed above was categorized as other and participants having all three reasons as listed above to participate in the study were included in All reasons category
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Participants | Number of Participants With Different Reasons for Participating in the Study | Have friend with DM/ to progress knowledge | 2 Participants |
| Healthy Participants | Number of Participants With Different Reasons for Participating in the Study | Other | 0 Participants |
| Healthy Participants | Number of Participants With Different Reasons for Participating in the Study | To improve medicines development | 10 Participants |
| Healthy Participants | Number of Participants With Different Reasons for Participating in the Study | All reasons | 0 Participants |
| Healthy Participants | Number of Participants With Different Reasons for Participating in the Study | Honorarium | 0 Participants |
| Participants With NOT1D | Number of Participants With Different Reasons for Participating in the Study | All reasons | 1 Participants |
| Participants With NOT1D | Number of Participants With Different Reasons for Participating in the Study | Have friend with DM/ to progress knowledge | 4 Participants |
| Participants With NOT1D | Number of Participants With Different Reasons for Participating in the Study | Honorarium | 0 Participants |
| Participants With NOT1D | Number of Participants With Different Reasons for Participating in the Study | Other | 1 Participants |
| Participants With NOT1D | Number of Participants With Different Reasons for Participating in the Study | To improve medicines development | 4 Participants |
Secondary
Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy
Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants with extreme anxiety towards the procedure have been presented.
Time frame: Up to Day 4
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Participants | Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy | 0 Participants |
| Participants With NOT1D | Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations.
Time frame: Up to Day 14
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Participants | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any SAE | 0 Participants |
| Healthy Participants | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any non-SAE | 9 Participants |
| Participants With NOT1D | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any SAE | 0 Participants |
| Participants With NOT1D | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Any non-SAE | 5 Participants |
Secondary
Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | B-cells; FNA; n=9, 4 | 10.48 Percentage of mononuclear cells | Standard Error 1.417 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | B-cells; Core; n=4, 8 | 7.29 Percentage of mononuclear cells | Standard Error 2.411 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56bright NK cells; FNA; n=9, 4 | 0.61 Percentage of mononuclear cells | Standard Error 0.11 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16+; FNA; n=9, 4 | 0.55 Percentage of mononuclear cells | Standard Error 0.215 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16+; Core; n=3, 8 | 0.82 Percentage of mononuclear cells | Standard Error 0.272 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16-; Core; n=3,7 | 0.18 Percentage of mononuclear cells | Standard Error 0.054 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | NK cells; Core; n=4, 8 | 1.27 Percentage of mononuclear cells | Standard Error 0.333 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56+CD16+; FNA; n=8, 2 | NA Percentage of mononuclear cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56+CD16+; Core; n=2, 7 | NA Percentage of mononuclear cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56bright NK cells; Core; n=4, 8 | 0.47 Percentage of mononuclear cells | Standard Error 0.118 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16-; FNA; n=8, 4 | 0.19 Percentage of mononuclear cells | Standard Error 0.042 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | Dendritic cells; FNA; n=9, 4 | 0.47 Percentage of mononuclear cells | Standard Error 0.061 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | Dendritic cells; Core; n=4, 8 | 0.44 Percentage of mononuclear cells | Standard Error 0.183 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | NK cells; FNA; n=9, 4 | 1.60 Percentage of mononuclear cells | Standard Error 0.425 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | NK cells; Core; n=4, 8 | 1.35 Percentage of mononuclear cells | Standard Error 0.251 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | B-cells; FNA; n=9, 4 | 5.51 Percentage of mononuclear cells | Standard Error 2.106 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56+CD16+; FNA; n=8, 2 | NA Percentage of mononuclear cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | Dendritic cells; FNA; n=9, 4 | 0.24 Percentage of mononuclear cells | Standard Error 0.097 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56bright NK cells; FNA; n=9, 4 | 0.47 Percentage of mononuclear cells | Standard Error 0.154 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56bright NK cells; Core; n=4, 8 | 0.53 Percentage of mononuclear cells | Standard Error 0.089 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56+CD16+; Core; n=2, 7 | NA Percentage of mononuclear cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16+; FNA; n=9, 4 | 0.94 Percentage of mononuclear cells | Standard Error 0.34 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | NK cells; FNA; n=9, 4 | 1.66 Percentage of mononuclear cells | Standard Error 0.637 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16-; FNA; n=8, 4 | 0.21 Percentage of mononuclear cells | Standard Error 0.053 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16+; Core; n=3, 8 | 0.45 Percentage of mononuclear cells | Standard Error 0.152 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | CD56lo CD16-; Core; n=3,7 | 0.21 Percentage of mononuclear cells | Standard Error 0.041 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | Dendritic cells; Core; n=4, 8 | 0.54 Percentage of mononuclear cells | Standard Error 0.125 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA | B-cells; Core; n=4, 8 | 9.17 Percentage of mononuclear cells | Standard Error 1.769 |
95% CI: [-0.54, 10.48]
95% CI: [-8.37, 4.61]
95% CI: [-0.26, 0.54]
95% CI: [-0.37, 0.27]
95% CI: [-1.27, 0.49]
95% CI: [-0.33, 1.07]
95% CI: [-0.16, 0.13]
95% CI: [-0.17, 0.12]
95% CI: [-0.03, 0.47]
95% CI: [-0.59, 0.4]
95% CI: [-1.72, 1.6]
95% CI: [-0.99, 0.82]
Secondary
Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Circulating B Lymphocytes; FNA; n=9,4 | 14.36 Percentage of B lymphocytes | Standard Error 2.104 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Double Negative B Lymphocytes; Core; n= 4, 8 | 8.89 Percentage of B lymphocytes | Standard Error 1.302 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Classical B Lymphocytes; Core; n= 4, 8 | 37.66 Percentage of B lymphocytes | Standard Error 4.711 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Classical B Lymphocytes; FNA; n=9,4 | 39.89 Percentage of B lymphocytes | Standard Error 4.438 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Circulating B Lymphocytes; Core; n=4, 8 | 16.66 Percentage of B lymphocytes | Standard Error 1.668 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Plasmablast; FNA; n=4, 3 | NA Percentage of B lymphocytes | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Naive B Lymphocytes;FNA; n=9,4 | 36.05 Percentage of B lymphocytes | Standard Error 3.545 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Naive B Lymphocytes; Core; n= 4, 8 | 35.60 Percentage of B lymphocytes | Standard Error 4.671 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Double Negative B Lymphocytes; FNA; n=9,4 | 8.48 Percentage of B lymphocytes | Standard Error 2.285 |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Transitional B Lymphocytes; FNA; n=2, 1 | NA Percentage of B lymphocytes | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Transitional B Lymphocytes;Core; n=1, 2 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Circulating B Lymphocytes; FNA; n=9,4 | 12.07 Percentage of B lymphocytes | Standard Error 2.272 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Transitional B Lymphocytes;Core; n=1, 2 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Classical B Lymphocytes; FNA; n=9,4 | 28.35 Percentage of B lymphocytes | Standard Error 6.283 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Naive B Lymphocytes;FNA; n=9,4 | 44.36 Percentage of B lymphocytes | Standard Error 4.939 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Naive B Lymphocytes; Core; n= 4, 8 | 43.91 Percentage of B lymphocytes | Standard Error 3.796 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Plasmablast; Core; n=0, 5 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Circulating B Lymphocytes; Core; n=4, 8 | 12.20 Percentage of B lymphocytes | Standard Error 1.633 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Classical B Lymphocytes; Core; n= 4, 8 | 32.02 Percentage of B lymphocytes | Standard Error 3.716 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Double Negative B Lymphocytes; FNA; n=9,4 | 9.85 Percentage of B lymphocytes | Standard Error 2.43 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Double Negative B Lymphocytes; Core; n= 4, 8 | 10.68 Percentage of B lymphocytes | Standard Error 1.177 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Plasmablast; FNA; n=4, 3 | NA Percentage of B lymphocytes | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA | Transitional B Lymphocytes; FNA; n=2, 1 | NA Percentage of B lymphocytes | — |
95% CI: [-4.24, 8.83]
95% CI: [-0.47, 9.39]
95% CI: [-5.24, 28.32]
95% CI: [-7.73, 19.01]
95% CI: [-8.46, 5.71]
95% CI: [-5.54, 1.98]
95% CI: [-21.58, 4.98]
95% CI: [-21.49, 4.87]
Secondary
Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA | CD14+ monocytes; ;FNA; n=5, 2 | NA Percentage of monocytes |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA | CD14+ monocytes;Core; n=3, 3 | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA | CD14+ CD16+ monocytes; ;FNA; n=0, 1 | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA | CD14+ monocytes; ;FNA; n=5, 2 | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA | CD14+ monocytes;Core; n=3, 3 | NA Percentage of monocytes |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA | CD16+ monocytes; ;FNA; n=0, 2 | NA Percentage of monocytes |
Secondary
Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Conv T cells;FNA;n=9, 4 | 3.02 Percentage of total Conv T cells | Standard Error 0.448 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Conv T cells; Core; n=5, 8 | 5.85 Percentage of total Conv T cells | Standard Error 0.892 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Conv T cells;FNA;n=10, 4 | 27.95 Percentage of total Conv T cells | Standard Error 3.498 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Conv T cells; Core; n=5, 9 | 27.54 Percentage of total Conv T cells | Standard Error 3.87 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Conv T cells ; FNA;n=10, 4 | 5.14 Percentage of total Conv T cells | Standard Error 0.75 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Conv T cells ; Core; n=5, 9 | 5.85 Percentage of total Conv T cells | Standard Error 0.644 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Conv T cells; FNA;n=9, 4 | 4.07 Percentage of total Conv T cells | Standard Error 0.76 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Conv T cells ; Core; n=5, 8 | 4.72 Percentage of total Conv T cells | Standard Error 0.502 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Conv T cells ; Core; n=5, 8 | 2.45 Percentage of total Conv T cells | Standard Error 0.505 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Conv T cells;FNA;n=9, 4 | 1.64 Percentage of total Conv T cells | Standard Error 0.533 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Conv T cells ; FNA;n=10, 4 | 5.27 Percentage of total Conv T cells | Standard Error 0.98 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Conv T cells; Core; n=5, 8 | 3.66 Percentage of total Conv T cells | Standard Error 0.978 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Conv T cells; FNA;n=9, 4 | 0.86 Percentage of total Conv T cells | Standard Error 0.935 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Conv T cells;FNA;n=10, 4 | 28.86 Percentage of total Conv T cells | Standard Error 5.346 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Conv T cells ; Core; n=5, 9 | 5.44 Percentage of total Conv T cells | Standard Error 0.57 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Conv T cells; Core; n=5, 9 | 31.73 Percentage of total Conv T cells | Standard Error 2.943 |
95% CI: [-0.08, 2.83]
95% CI: [-0.61, 4.98]
95% CI: [-14.66, 12.85]
95% CI: [-14.71, 6.33]
95% CI: [-2.73, 2.47]
95% CI: [-1.45, 2.28]
95% CI: [0.64, 5.78]
95% CI: [0.75, 3.79]
Secondary
Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Memory Conv T cells; FNA; n=9, 4 | 6.39 Percentage of total memory Conv cells | Standard Error 0.889 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Memory Conv T cells; Core; n=5, 8 | 8.80 Percentage of total memory Conv cells | Standard Error 1.39 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Memory Conv T cells; FNA; n=10, 4 | 45.74 Percentage of total memory Conv cells | Standard Error 3.604 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Memory Conv T cells; Core; n=5, 9 | 42.91 Percentage of total memory Conv cells | Standard Error 3.198 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Memory Conv T cells; FNA; n=9, 4 | 7.68 Percentage of total memory Conv cells | Standard Error 1.312 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Memory Conv T cells; Core; n=5, 9 | 8.82 Percentage of total memory Conv cells | Standard Error 2.144 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Memory Conv T cells; FNA; n=9, 4 | 4.32 Percentage of total memory Conv cells | Standard Error 0.659 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Memory Conv T cells; Core; n=4, 8 | 4.63 Percentage of total memory Conv cells | Standard Error 0.482 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Memory Conv T cells; Core; n=4, 8 | 3.04 Percentage of total memory Conv cells | Standard Error 0.558 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Memory Conv T cells; FNA; n=9, 4 | 3.12 Percentage of total memory Conv cells | Standard Error 1.042 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Memory Conv T cells; FNA; n=9, 4 | 6.35 Percentage of total memory Conv cells | Standard Error 2.661 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Memory Conv T cells; Core; n=5, 8 | 6.06 Percentage of total memory Conv cells | Standard Error 1.585 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Ki67+ Memory Conv T cells; FNA; n=9, 4 | 1.62 Percentage of total memory Conv cells | Standard Error 0.777 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Memory Conv T cells; FNA; n=10, 4 | 45.74 Percentage of total memory Conv cells | Standard Error 5.662 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | Helios+ Memory Conv T cells; Core; n=5, 9 | 7.59 Percentage of total memory Conv cells | Standard Error 0.794 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA | CD69+ Memory Conv T cells; Core; n=5, 9 | 47.03 Percentage of total memory Conv cells | Standard Error 2.314 |
95% CI: [0.4, 6.15]
95% CI: [-1.68, 7.17]
95% CI: [-14.49, 14.48]
95% CI: [-12.67, 4.43]
95% CI: [-5.48, 8.13]
95% CI: [-4.36, 6.84]
95% CI: [0.54, 4.84]
95% CI: [0.03, 3.13]
Secondary
Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Helios+ Reg T cells; Core; n=5, 9 | 81.68 Percentage of T Reg cells | Standard Error 2.18 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Reg T cells; FNA; n=9, 4 | 12.99 Percentage of T Reg cells | Standard Error 2.022 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Reg T cells; Core; n=4, 8 | 20.10 Percentage of T Reg cells | Standard Error 4.531 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD69+ Reg T cells; FNA; n=10, 4 | 48.55 Percentage of T Reg cells | Standard Error 3.666 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD69+ Reg T cells; Core; n=5, 9 | 47.48 Percentage of T Reg cells | Standard Error 2.744 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Helios+ Reg T cells; FNA; n=10, 4 | 80.88 Percentage of T Reg cells | Standard Error 1.559 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Ki67+ T Reg cells; FNA; n=8, 4 | 8.02 Percentage of T Reg cells | Standard Error 1.855 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Ki67+ T Reg cells; Core; n=4, 7 | 8.76 Percentage of T Reg cells | Standard Error 0.893 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Memory Reg T cells; FNA; n=10, 4 | 47.10 Percentage of T Reg cells | Standard Error 2.842 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Memory Reg T cells; Core; n=5, 9 | 53.13 Percentage of T Reg cells | Standard Error 3.036 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Resting Reg T cells; FNA; n=9, 4 | 38.09 Percentage of T Reg cells | Standard Error 3.392 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Resting Reg T cells; Core; n=5, 9 | 32.54 Percentage of T Reg cells | Standard Error 3.828 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Resting Reg T cells; FNA; n=9, 4 | 27.64 Percentage of T Reg cells | Standard Error 4.692 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Ki67+ T Reg cells; FNA; n=8, 4 | 4.80 Percentage of T Reg cells | Standard Error 2.072 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Reg T cells; FNA; n=9, 4 | 8.13 Percentage of T Reg cells | Standard Error 2.327 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Memory Reg T cells; Core; n=5, 9 | 51.25 Percentage of T Reg cells | Standard Error 2.818 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD15s+ Reg T cells; Core; n=4, 8 | 11.89 Percentage of T Reg cells | Standard Error 5.044 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Ki67+ T Reg cells; Core; n=4, 7 | 5.38 Percentage of T Reg cells | Standard Error 0.996 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD69+ Reg T cells; FNA; n=10, 4 | 59.74 Percentage of T Reg cells | Standard Error 4.51 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Resting Reg T cells; Core; n=5, 9 | 26.37 Percentage of T Reg cells | Standard Error 3.08 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | CD69+ Reg T cells; Core; n=5, 9 | 53.37 Percentage of T Reg cells | Standard Error 2.708 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Memory Reg T cells; FNA; n=10, 4 | 48.55 Percentage of T Reg cells | Standard Error 3.788 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Helios+ Reg T cells; FNA; n=10, 4 | 79.23 Percentage of T Reg cells | Standard Error 1.929 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA | Helios+ Reg T cells; Core; n=5, 9 | 79.10 Percentage of T Reg cells | Standard Error 1.968 |
95% CI: [-1.6, 11.31]
95% CI: [-6.15, 22.57]
95% CI: [-23.48, 1.11]
95% CI: [-14.14, 2.37]
95% CI: [-3.54, 6.84]
95% CI: [-3.84, 8.98]
95% CI: [-2.67, 9.12]
95% CI: [0.55, 6.21]
95% CI: [-11.49, 8.58]
95% CI: [-6.81, 10.58]
95% CI: [-2.01, 22.92]
95% CI: [-4.24, 16.59]
Secondary
Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory CD8; FNA; n=12, 8 | 11.96 Percentage of CD8 T cells | Standard Error 2.298 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory CD8; Core; n=11, 10 | 17.12 Percentage of CD8 T cells | Standard Error 2.342 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Central Memory CD8; FNA; n=12, 7 | 4.84 Percentage of CD8 T cells | Standard Error 0.895 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Central Memory CD8; Core; n=11, 10 | 6.25 Percentage of CD8 T cells | Standard Error 1.264 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Effector Memory CD8; FNA; n=12, 8 | 11.32 Percentage of CD8 T cells | Standard Error 2.026 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Effector Memory CD8; Core; n= 11, 10 | 16.16 Percentage of CD8 T cells | Standard Error 2.105 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Naive CD8; FNA; n=12, 8 | 61.17 Percentage of CD8 T cells | Standard Error 4.306 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Naive CD8; Core; n=11, 10 | 49.07 Percentage of CD8 T cells | Standard Error 4.888 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like CD8;FNA; n= 12, 6 | 1.73 Percentage of CD8 T cells | Standard Error 0.428 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like CD8; Core; 9,10 | 1.64 Percentage of CD8 T cells | Standard Error 0.257 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Naive CD8; Core; n=11, 10 | 51.25 Percentage of CD8 T cells | Standard Error 5.224 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory CD8; FNA; n=12, 8 | 13.58 Percentage of CD8 T cells | Standard Error 2.721 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Effector Memory CD8; Core; n= 11, 10 | 17.76 Percentage of CD8 T cells | Standard Error 2.236 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory CD8; Core; n=11, 10 | 13.11 Percentage of CD8 T cells | Standard Error 2.489 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like CD8; Core; 9,10 | 2.06 Percentage of CD8 T cells | Standard Error 0.269 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Central Memory CD8; FNA; n=12, 7 | 5.00 Percentage of CD8 T cells | Standard Error 1.113 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Naive CD8; FNA; n=12, 8 | 57.65 Percentage of CD8 T cells | Standard Error 4.994 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Central Memory CD8; Core; n=11, 10 | 7.41 Percentage of CD8 T cells | Standard Error 1.352 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like CD8;FNA; n= 12, 6 | 2.65 Percentage of CD8 T cells | Standard Error 0.563 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA | Effector Memory CD8; FNA; n=12, 8 | 13.43 Percentage of CD8 T cells | Standard Error 2.389 |
95% CI: [-9.05, 5.82]
95% CI: [-3.13, 11.16]
95% CI: [-3.14, 2.82]
95% CI: [-5.03, 2.71]
95% CI: [-8.65, 4.43]
95% CI: [-8, 4.81]
95% CI: [-10.21, 17.24]
95% CI: [-17.1, 12.74]
95% CI: [-2.42, 0.58]
95% CI: [-1.19, 0.35]
Secondary
Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16+; Core; n=3, 8 | 39.58 Percentage of NK cells | Standard Error 11.072 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56+CD16+; Core; n=2, 7 | NA Percentage of NK cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16-; FNA; n=8, 4 | 13.17 Percentage of NK cells | Standard Error 1.321 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56+CD16+; FNA; n=8, 2 | NA Percentage of NK cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56bright NK cells; FNA; n=9, 4 | 40.37 Percentage of NK cells | Standard Error 3.934 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16+; FNA; n=9, 4 | 34.66 Percentage of NK cells | Standard Error 4.476 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16-; Core; n=3, 7 | 12.42 Percentage of NK cells | Standard Error 3.479 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56bright NK cells; Core; n=4, 8 | 43.32 Percentage of NK cells | Standard Error 6.34 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16-; Core; n=3, 7 | 15.21 Percentage of NK cells | Standard Error 2.258 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56+CD16+; Core; n=2, 7 | NA Percentage of NK cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56bright NK cells; FNA; n=9, 4 | 26.65 Percentage of NK cells | Standard Error 6.356 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56bright NK cells; Core; n=4, 8 | 43.36 Percentage of NK cells | Standard Error 4.129 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16+; FNA; n=9, 4 | 54.69 Percentage of NK cells | Standard Error 7.327 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16+; Core; n=3, 8 | 35.32 Percentage of NK cells | Standard Error 6.3 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56lo CD16-; FNA; n=8, 4 | 13.31 Percentage of NK cells | Standard Error 2.039 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA | CD56+CD16+; FNA; n=8, 2 | NA Percentage of NK cells | — |
95% CI: [-2.72, 30.15]
95% CI: [-16.85, 16.78]
95% CI: [-38.98, -1.08]
95% CI: [-24.14, 32.65]
95% CI: [-5.54, 5.26]
95% CI: [-12.31, 6.73]
Secondary
Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | CD69+ CD8 cells; FNA; n=10, 4 | 16.80 Percentage of CD8 T cells | Standard Error 2.837 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | CD69+ CD8 cells; Core; n=5, 9 | 18.74 Percentage of CD8 T cells | Standard Error 4.287 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | Ki67+ CD8 cells; FNA; n=9, 3 | 4.82 Percentage of CD8 T cells | Standard Error 0.689 |
| Healthy Participants | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | Ki67+ CD8 cells; Core; n=4, 6 | 6.90 Percentage of CD8 T cells | Standard Error 1.025 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | Ki67+ CD8 cells; Core; n=4, 6 | 3.99 Percentage of CD8 T cells | Standard Error 0.785 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | CD69+ CD8 cells; FNA; n=10, 4 | 17.97 Percentage of CD8 T cells | Standard Error 4.201 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | Ki67+ CD8 cells; FNA; n=9, 3 | 3.33 Percentage of CD8 T cells | Standard Error 1.189 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA | CD69+ CD8 cells; Core; n=5, 9 | 23.12 Percentage of CD8 T cells | Standard Error 3.117 |
95% CI: [-11.91, 9.58]
95% CI: [-15.85, 7.1]
95% CI: [-1.62, 4.59]
95% CI: [-0.05, 5.88]
Secondary
Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory Conv T cells; FNA; n=12, 7 | 1.16 Percentage of total Conv T cell | Standard Error 0.221 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory Conv T cells;Core;n=11, 10 | 1.13 Percentage of total Conv T cell | Standard Error 0.126 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Central Memory Conv T cells; FNA; n= 12, 8 | 21.15 Percentage of total Conv T cell | Standard Error 2.765 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Central Memory Conv T cells; Core; n= 11, 10 | 24.99 Percentage of total Conv T cell | Standard Error 2.881 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Effector Memory Conv T cells; FNA; n=12, 8 | 17.71 Percentage of total Conv T cell | Standard Error 2.605 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Effector Memory Conv T cells; Core; n=11, 10 | 23.16 Percentage of total Conv T cell | Standard Error 2.736 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Naive Conv T cells; FNA; n=12,8 | 50.43 Percentage of total Conv T cell | Standard Error 3.672 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Naive Conv T cells; Core; n=11, 10 | 41.82 Percentage of total Conv T cell | Standard Error 3.421 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like Conv T cells; FNA; n=12, 7 | 1.39 Percentage of total Conv T cell | Standard Error 0.191 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like Conv T cells; Core; n=11, 10 | 1.31 Percentage of total Conv T cell | Standard Error 0.224 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Naive Conv T cells; Core; n=11, 10 | 41.34 Percentage of total Conv T cell | Standard Error 3.614 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory Conv T cells; FNA; n=12, 7 | 0.77 Percentage of total Conv T cell | Standard Error 0.282 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Effector Memory Conv T cells; Core; n=11, 10 | 21.10 Percentage of total Conv T cell | Standard Error 2.909 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | CD45RA+ Effector Memory Conv T cells;Core;n=11, 10 | 0.99 Percentage of total Conv T cell | Standard Error 0.133 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like Conv T cells; Core; n=11, 10 | 1.73 Percentage of total Conv T cell | Standard Error 0.236 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Central Memory Conv T cells; FNA; n= 12, 8 | 21.34 Percentage of total Conv T cell | Standard Error 3.188 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Naive Conv T cells; FNA; n=12,8 | 52.52 Percentage of total Conv T cell | Standard Error 4.395 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Central Memory Conv T cells; Core; n= 11, 10 | 28.71 Percentage of total Conv T cell | Standard Error 3.087 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Stem Cell Memory-like Conv T cells; FNA; n=12, 7 | 1.40 Percentage of total Conv T cell | Standard Error 0.249 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA | Effector Memory Conv T cells; FNA; n=12, 8 | 15.46 Percentage of total Conv T cell | Standard Error 3.08 |
95% CI: [-0.36, 1.14]
95% CI: [-0.25, 0.52]
95% CI: [-9.02, 8.64]
95% CI: [-12.57, 5.13]
95% CI: [-6.16, 10.66]
95% CI: [-6.27, 10.39]
95% CI: [-14.09, 9.92]
95% CI: [-9.91, 10.87]
95% CI: [-0.67, 0.65]
95% CI: [-1.1, 0.26]
Secondary
Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Myeloid Dendritic cells; FNA; n=8, 4 | 46.76 Percentage of total dendritic cells | Standard Error 4.383 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Myeloid Dendritic cells; Core; n=4 ,8 | 39.16 Percentage of total dendritic cells | Standard Error 4.626 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Plasmacytoid Dendritic cells; FNA; n=9, 3 | 54.59 Percentage of total dendritic cells | Standard Error 5.834 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Plasmacytoid Dendritic cells; Core; n=4, 8 | 60.27 Percentage of total dendritic cells | Standard Error 4.185 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Plasmacytoid Dendritic cells; Core; n=4, 8 | 74.12 Percentage of total dendritic cells | Standard Error 3.988 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Myeloid Dendritic cells; FNA; n=8, 4 | 38.50 Percentage of total dendritic cells | Standard Error 6.298 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Plasmacytoid Dendritic cells; FNA; n=9, 3 | 62.48 Percentage of total dendritic cells | Standard Error 8.742 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA | Myeloid Dendritic cells; Core; n=4 ,8 | 22.95 Percentage of total dendritic cells | Standard Error 4.111 |
95% CI: [-8.58, 25.08]
95% CI: [3.17, 29.26]
95% CI: [-31.03, 15.25]
95% CI: [-26.04, -1.66]
Secondary
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cell-like Reg T cells; FNA;n=2, 3 | NA Percentage of TFH cell-like Reg T Cells |
| Healthy Participants | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cell-like Reg T cells; Core; n=4,5 | NA Percentage of TFH cell-like Reg T Cells |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cell-like Reg T cells; FNA;n=2, 3 | NA Percentage of TFH cell-like Reg T Cells |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cell-like Reg T cells; Core; n=4,5 | NA Percentage of TFH cell-like Reg T Cells |
Secondary
Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; FNA; n=8, 4 | 3.95 Percentage of TFH cells | Standard Error 1.601 |
| Healthy Participants | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; Core; n=6, 10 | 1.55 Percentage of TFH cells | Standard Error 5.416 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; FNA; n=8, 4 | 9.34 Percentage of TFH cells | Standard Error 1.977 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; Core; n=6, 10 | 8.58 Percentage of TFH cells | Standard Error 4.613 |
95% CI: [-11.56, 0.78]
95% CI: [-22.22, 8.16]
Secondary
Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA | Reg T cells; FNA; n=10, 4 | 11.98 Percentage of CD4 T cells | Standard Error 0.75 |
| Healthy Participants | Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA | Reg T cells; Core; n=5, 9 | 12.11 Percentage of CD4 T cells | Standard Error 0.871 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA | Reg T cells; FNA; n=10, 4 | 11.52 Percentage of CD4 T cells | Standard Error 1.067 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA | Reg T cells; Core; n=5, 9 | 13.05 Percentage of CD4 T cells | Standard Error 0.597 |
95% CI: [-2.27, 3.19]
95% CI: [-3.24, 1.36]
Secondary
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 cells; Core; n=11,10 | 16.09 Percenatge of total memory Conv T cells | Standard Error 1.858 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TFH cells; ; FNA; n=12, 8 | 24.09 Percenatge of total memory Conv T cells | Standard Error 2.913 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TFH cells; Core; n=11,10 | 21.94 Percenatge of total memory Conv T cells | Standard Error 3.335 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; FNA; n=8,4 | 0.89 Percenatge of total memory Conv T cells | Standard Error 0.356 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; Core; n=6,10 | 1.72 Percenatge of total memory Conv T cells | Standard Error 1.239 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH17 cells;FNA; n=12,8 | 7.73 Percenatge of total memory Conv T cells | Standard Error 1.122 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH17 cells; Core; n=11,10 | 5.38 Percenatge of total memory Conv T cells | Standard Error 0.915 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 cells; FNA; n=12,8 | 14.08 Percenatge of total memory Conv T cells | Standard Error 2.34 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 cells; FNA; n=10,4 | 2.97 Percenatge of total memory Conv T cells | Standard Error 0.51 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 cells; Core; n=10,10 | 3.08 Percenatge of total memory Conv T cells | Standard Error 0.553 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 T cells; FNA; n=10,4 | 1.87 Percenatge of total memory Conv T cells | Standard Error 0.371 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 T cells; Core; n=10,10 | 2.01 Percenatge of total memory Conv T cells | Standard Error 0.39 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells; FNA; n=12,6 | 6.20 Percenatge of total memory Conv T cells | Standard Error 0.91 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells; Core; n=10, 10 | 9.25 Percenatge of total memory Conv T cells | Standard Error 1.13 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH2 cells; FNA; n=12,8 | 20.82 Percenatge of total memory Conv T cells | Standard Error 2.168 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH2 cells; Core; n=11,10 | 19.24 Percenatge of total memory Conv T cells | Standard Error 1.685 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH22 cells; FNA; n=12,4 | 1.51 Percenatge of total memory Conv T cells | Standard Error 0.336 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH22 cells; Core; n=10, 10 | 1.49 Percenatge of total memory Conv T cells | Standard Error 0.308 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells; Core; n=10, 10 | 8.83 Percenatge of total memory Conv T cells | Standard Error 1.147 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 cells; Core; n=10,10 | 2.49 Percenatge of total memory Conv T cells | Standard Error 0.559 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TFH cells; ; FNA; n=12, 8 | 17.09 Percenatge of total memory Conv T cells | Standard Error 3.651 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH22 cells; Core; n=10, 10 | 1.50 Percenatge of total memory Conv T cells | Standard Error 0.311 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TFH cells; Core; n=11,10 | 25.86 Percenatge of total memory Conv T cells | Standard Error 3.491 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 T cells; FNA; n=10,4 | 1.44 Percenatge of total memory Conv T cells | Standard Error 0.488 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; FNA; n=8,4 | 2.15 Percenatge of total memory Conv T cells | Standard Error 0.545 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH2 cells; FNA; n=12,8 | 18.67 Percenatge of total memory Conv T cells | Standard Error 2.562 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells; Core; n=6,10 | 1.71 Percenatge of total memory Conv T cells | Standard Error 0.859 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 T cells; Core; n=10,10 | 1.63 Percenatge of total memory Conv T cells | Standard Error 0.409 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH17 cells;FNA; n=12,8 | 6.96 Percenatge of total memory Conv T cells | Standard Error 1.289 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH22 cells; FNA; n=12,4 | 1.46 Percenatge of total memory Conv T cells | Standard Error 0.53 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH17 cells; Core; n=11,10 | 5.33 Percenatge of total memory Conv T cells | Standard Error 0.977 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells; FNA; n=12,6 | 5.68 Percenatge of total memory Conv T cells | Standard Error 1.25 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 cells; FNA; n=12,8 | 15.05 Percenatge of total memory Conv T cells | Standard Error 2.777 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 cells; Core; n=11,10 | 22.12 Percenatge of total memory Conv T cells | Standard Error 1.97 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH2 cells; Core; n=11,10 | 15.29 Percenatge of total memory Conv T cells | Standard Error 1.821 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 cells; FNA; n=10,4 | 3.07 Percenatge of total memory Conv T cells | Standard Error 0.728 |
95% CI: [-2.8, 16.81]
95% CI: [-14.02, 6.17]
95% CI: [-2.69, 0.16]
95% CI: [-3.21, 3.24]
95% CI: [-2.78, 4.33]
95% CI: [-2.75, 2.85]
95% CI: [-8.56, 6.63]
95% CI: [-11.69, -0.38]
95% CI: [-1.98, 1.78]
95% CI: [-1.07, 2.24]
95% CI: [-0.85, 1.72]
95% CI: [-0.8, 1.56]
95% CI: [-2.71, 3.76]
95% CI: [-2.95, 3.79]
95% CI: [-4.84, 9.14]
95% CI: [-1.25, 9.15]
95% CI: [-1.28, 1.38]
95% CI: [-0.93, 0.91]
Secondary
Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA
Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.
Time frame: Biopsy session on Day 1
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TFH cells-like Reg T cells; FNA; n=11, 5 | 13.52 Percentage of total memory Reg T cells | Standard Error 2.224 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells-like Reg T cells;FNA; n=11, 4 | 9.08 Percentage of total memory Reg T cells | Standard Error 1.092 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 cells-like Reg T cells;Core;n=8, 10 | 7.43 Percentage of total memory Reg T cells | Standard Error 1.211 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells-like Reg T cells;Core; n=10,10 | 11.15 Percentage of total memory Reg T cells | Standard Error 1.434 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells-like Reg T cells;FNA;n=2,3 | NA Percentage of total memory Reg T cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH17 cells-like Reg T cells;FNA; n=11, 4 | 8.18 Percentage of total memory Reg T cells | Standard Error 1.547 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH17-like Reg T cells;FNA; n=1, 1 | NA Percentage of total memory Reg T cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH17 cells-like Reg T cells;Core; n=10, 10 | 6.23 Percentage of total memory Reg T cells | Standard Error 1.507 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells-like Reg T cells;Core;n=4,5 | NA Percentage of total memory Reg T cells | — |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH2 cells-like Reg T cells;FNA; n=12, 8 | 27.38 Percentage of total memory Reg T cells | Standard Error 2.749 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TFH cells-like Reg T cells; Core; n=9, 10 | 13.44 Percentage of total memory Reg T cells | Standard Error 1.884 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH2 cells-like Reg T cells;Core; n=11, 10 | 28.28 Percentage of total memory Reg T cells | Standard Error 2.386 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 cells-like Reg T cells;FNA; n=7, 4 | 2.88 Percentage of total memory Reg T cells | Standard Error 0.599 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH22 cells-like Reg T cells;FNA; n=6,3 | 2.30 Percentage of total memory Reg T cells | Standard Error 0.653 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 cells-like Reg T cells;FNA; n=11,5 | 7.19 Percentage of total memory Reg T cells | Standard Error 1.428 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH22 cells-like Reg T cells;Core; n=7,7 | 2.28 Percentage of total memory Reg T cells | Standard Error 0.619 |
| Healthy Participants | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 cells-like Reg T cells;Core;n=5,5 | 2.25 Percentage of total memory Reg T cells | Standard Error 1.381 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells-like Reg T cells;FNA;n=2,3 | NA Percentage of total memory Reg T cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH22 cells-like Reg T cells;Core; n=7,7 | 2.45 Percentage of total memory Reg T cells | Standard Error 0.61 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TFH cells-like Reg T cells; FNA; n=11, 5 | 13.22 Percentage of total memory Reg T cells | Standard Error 2.869 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TFH cells-like Reg T cells; Core; n=9, 10 | 12.71 Percentage of total memory Reg T cells | Standard Error 1.926 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | PD-1+ ICOS+ TFH cells-like Reg T cells;Core;n=4,5 | NA Percentage of total memory Reg T cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 cells-like Reg T cells;FNA; n=11,5 | 12.09 Percentage of total memory Reg T cells | Standard Error 1.9 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 cells-like Reg T cells;Core;n=8, 10 | 10.72 Percentage of total memory Reg T cells | Standard Error 1.167 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH17-like Reg T cells;FNA; n=1, 1 | NA Percentage of total memory Reg T cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH17-like Reg T cells;Core; n=0,2 | NA Percentage of total memory Reg T cells | — |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 cells-like Reg T cells;FNA; n=7, 4 | 3.17 Percentage of total memory Reg T cells | Standard Error 0.845 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH17 TH2 cells-like Reg T cells;Core;n=5,5 | 5.05 Percentage of total memory Reg T cells | Standard Error 1.348 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells-like Reg T cells;FNA; n=11, 4 | 10.52 Percentage of total memory Reg T cells | Standard Error 1.813 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH1 TH2 cells-like Reg T cells;Core; n=10,10 | 11.45 Percentage of total memory Reg T cells | Standard Error 1.46 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH17 cells-like Reg T cells;FNA; n=11, 4 | 9.64 Percentage of total memory Reg T cells | Standard Error 2.146 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH17 cells-like Reg T cells;Core; n=10, 10 | 5.70 Percentage of total memory Reg T cells | Standard Error 1.582 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH2 cells-like Reg T cells;FNA; n=12, 8 | 29.63 Percentage of total memory Reg T cells | Standard Error 3.305 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH2 cells-like Reg T cells;Core; n=11, 10 | 24.86 Percentage of total memory Reg T cells | Standard Error 2.522 |
| Participants With NOT1D | Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA | TH22 cells-like Reg T cells;FNA; n=6,3 | 2.95 Percentage of total memory Reg T cells | Standard Error 0.95 |
95% CI: [-7.4, 8]
95% CI: [-4.9, 6.35]
95% CI: [-9.89, 0.08]
95% CI: [-6.82, 0.24]
95% CI: [-2.67, 2.1]
95% CI: [-7.2, 1.59]
95% CI: [-5.98, 3.11]
95% CI: [-4.59, 3.99]
95% CI: [-6.99, 4.06]
95% CI: [-4.05, 5.11]
95% CI: [-11.23, 6.73]
95% CI: [-3.84, 10.67]
95% CI: [-3.3, 2]
95% CI: [-2.06, 1.72]