Neoplasms
Conditions
Keywords
Adoptive T-cell therapy, Hematologic Malignancy, Human leukocyte antigen, Screening study, Solid Tumors, T-cell receptors
Brief summary
This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.
Interventions
OTHERScreening Platform
Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types . * Participant must be greater than or equal to (\>=)18 years of age (or \>=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma \[MRCLS\]) * Participants with life expectancy of greater than 6 months * Performance status: Eastern Cooperative Oncology Group 0-1.
Exclusion criteria
* Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor) * Prior malignancy not in complete remission. * Clinically significant systemic illness * Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, * Prior or active demyelinating disease * Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody. * Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status | Up to 2 weeks | Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous. |
Countries
United States
Participant flow
Recruitment details
This screening study was intended to determine potential eligibility of participants for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. The study was terminated early due to feasibility reasons.
Pre-assignment details
A total of 16 participants were enrolled in the study and provided blood sample for biomarker assessment.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Non-small Cell Lung Cancer (NSCLC) Participants with NSCLC were screened for appropriate biomarkers for an intended adoptive cell therapy on a separate treatment trial. No study treatment was administered in this study. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Participants With Non-small Cell Lung Cancer (NSCLC) |
|---|---|
| Age, Continuous | 63.8 Years STANDARD_DEVIATION 7.49 |
| Race/Ethnicity, Customized ASIAN - JAPANESE HERITAGE | 1 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 2 Participants |
| Race/Ethnicity, Customized WHITE-WHITE/CAUCASIAN/EUROPEAN HERITAGE | 13 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous.
Time frame: Up to 2 weeks
Population: Enrolled population included all participants who provided sample for biomarker assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status | One HLA Allele Positive | 9 Participants |
| Participants With Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status | Two HLA Allele Positive | 1 Participants |
| Participants With Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status | Negative | 6 Participants |
| Participants With Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status | Ambiguous | 0 Participants |