Multiple Sclerosis
Conditions
Keywords
multiple sclerosis
Brief summary
This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.
Interventions
BIOLOGICALUblituximab
Administered as an IV infusion.
DRUGPlacebo
Sponsors
TG Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of relapsing multiple sclerosis * Active disease * Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion
Exclusion criteria
* Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months * Treatment with alemtuzumab within the last 12 months * Pregnant or nursing mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate of B-Cell Depletion at Week 4 | Week 4 | Responders Rate is defined as percentage of participants with greater than or equal to (≥) 95% reduction of B cells (cluster of differentiation 19 positive \[CD19+\] cells) within 2 weeks after the second infusion (Day 15). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Weeks 24 and 48 | The new or enlarging T2 lesions were evaluated using MRI technique. |
| Annualized Relapse Rate (ARR) | Week 48 | ARR at Week 48 is calculated as the ratio of the sum of all participants confirmed relapse counts divided by the sum of all participants treatment duration (in years). |
| Relapse Rate Reduction (RRR) | Baseline to Week 48 | RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48. |
| Percentage of Relapse Free Participants | Week 48 | Participant was considered as free of clinical relapse if participant had no confirmed clinical relapse before treatment discontinuation/until end of Week 48. Relapses are defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS), and immediately preceded by a stable or improving neurological state of at least 30 days. |
| Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 plus 2 days, Weeks 25, 28, 36, 40, 44 and 48 | Cluster of Differentiation (CD)19 is a marker of B cells, the protein has been used to diagnose cancers that arise from this type of cell - notably B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The majority of B cell malignancies express normal to high levels of CD19. Memory B cell is a type of B lymphocyte that forms part of the adaptive immune system. These cells develop within germinal centers of the secondary lymphoid organs. Their function is to memorize the characteristics of the antigen that activated their parent B cell during initial infection such that if the memory B cell later encounters the same antigen, it triggers an accelerated and robust secondary immune response. A naive B cell is a B cell that has not been exposed to an antigen. Once exposed to an antigen, the naive B cell either becomes a memory B cell or a plasma cell that secretes antibodies specific to the antigen that was originally bound. |
| Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Weeks 24 and 48 | The Gd-enhancing T1 lesions were evaluated using magnetic resonance imaging (MRI) technique. |
| Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48 | A blood sample was collected and was sent to the laboratory for analysis of CD4+. |
| Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48 | A blood sample was collected and was sent to the laboratory for analysis of CD8+. |
| Additional Immune Profiling-Interleukin 10 (IL10) | Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48 | A blood sample was collected and was sent to the laboratory for analysis of IL-10. IL-10 is an anti-inflammatory cytokine that maintains the balance of the immune response, allowing the clearance of infection while minimizing damage to the host. |
| Additional Immune Profiling-Natural Killer (NK) Cells | Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48 | A blood sample was collected and was sent to the laboratory for analysis of NK cells. Percentage of NK cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation. |
| Pharmacokinetic Parameter: Plasma Concentration of Ublituximab | Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25 | Plasma concentration is defined as the measured concentration of ublituximab. |
| Change From Baseline in Sustained B Cell | Baseline to pre-dose at Week 24 and Week 48 | Sustained B cell reduction is defined as B-cell reductions achieved on pre-dose at Week 24 and Week 48. |
Countries
United States
Participant flow
Pre-assignment details
A total of 49 participants were randomized in this study. One participant was treated with placebo only; 12 participants were treated with placebo prior to treatment with ublituximab.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. | 8 |
| Cohort 2 Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. | 8 |
| Cohort 3 Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. | 8 |
| Cohort 4 Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. | 8 |
| Cohort 5 Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. | 8 |
| Cohort 6 Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. | 8 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Missing | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 | Total | Cohort 6 | Cohort 5 | Cohort 4 | Cohort 3 | Cohort 2 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 12.09 | 39.4 years STANDARD_DEVIATION 9.7 | 36.5 years STANDARD_DEVIATION 8.33 | 43.5 years STANDARD_DEVIATION 6.39 | 35.1 years STANDARD_DEVIATION 9.22 | 44.9 years STANDARD_DEVIATION 9.06 | 34.3 years STANDARD_DEVIATION 9.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 9 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 39 Participants | 5 Participants | 7 Participants | 6 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants | 7 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 6 Participants | 39 Participants | 6 Participants | 8 Participants | 6 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Female | 5 Participants | 32 Participants | 3 Participants | 8 Participants | 5 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 16 Participants | 5 Participants | 0 Participants | 3 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 13 |
| other Total, other adverse events | 8 / 8 | 7 / 8 | 8 / 8 | 8 / 8 | 8 / 8 | 8 / 8 | 12 / 13 |
| serious Total, serious adverse events | 0 / 8 | 1 / 8 | 2 / 8 | 0 / 8 | 0 / 8 | 2 / 8 | 0 / 13 |
Outcome results
Primary
Responder Rate of B-Cell Depletion at Week 4
Responders Rate is defined as percentage of participants with greater than or equal to (≥) 95% reduction of B cells (cluster of differentiation 19 positive \[CD19+\] cells) within 2 weeks after the second infusion (Day 15).
Time frame: Week 4
Population: ITT population included all participants who received at least one dose of ublituximab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Responder Rate of B-Cell Depletion at Week 4 | 87.5 percentage of participants |
| Cohort 2 | Responder Rate of B-Cell Depletion at Week 4 | 100.0 percentage of participants |
| Cohort 3 | Responder Rate of B-Cell Depletion at Week 4 | 87.5 percentage of participants |
| Cohort 4 | Responder Rate of B-Cell Depletion at Week 4 | 100.0 percentage of participants |
| Cohort 5 | Responder Rate of B-Cell Depletion at Week 4 | 100.0 percentage of participants |
| Cohort 6 | Responder Rate of B-Cell Depletion at Week 4 | 100.0 percentage of participants |
Secondary
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
A blood sample was collected and was sent to the laboratory for analysis of CD4+.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Population: ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 36 | 26.79 cells per cubic millimeter (cells/mm^3) | Standard Deviation 14.209 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 1 Day 2 | 22.71 cells per cubic millimeter (cells/mm^3) | Standard Deviation 15.829 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 28 | 20.03 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.87 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 44 | 24.77 cells per cubic millimeter (cells/mm^3) | Standard Deviation 6.469 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 3 Day 15 | 23.74 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.399 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 | 29.24 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.678 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 8 | 29.74 cells per cubic millimeter (cells/mm^3) | Standard Deviation 15.735 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 Plus 2 Days | 26.25 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.12 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 40 | 25.31 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.664 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 25 | 30.70 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.594 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 4 | 26.19 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.922 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 16 | 24.03 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.04 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Baseline | 28.73 cells per cubic millimeter (cells/mm^3) | Standard Deviation 12.195 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 48 | 26.72 cells per cubic millimeter (cells/mm^3) | Standard Deviation 6.914 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 12 | 24.20 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.152 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 2 | 34.01 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.19 |
| Cohort 1 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 20 | 22.94 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.492 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 44 | 29.84 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.013 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 25 | 27.31 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.091 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 | 29.36 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.856 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 Plus 2 Days | 27.54 cells per cubic millimeter (cells/mm^3) | Standard Deviation 5.269 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 1 Day 2 | 27.52 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.388 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 2 | 39.83 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.829 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Baseline | 35.39 cells per cubic millimeter (cells/mm^3) | Standard Deviation 4.628 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 48 | 32.92 cells per cubic millimeter (cells/mm^3) | Standard Deviation 6.697 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 3 Day 15 | 26.51 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.65 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 12 | 32.26 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.118 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 40 | 30.91 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.601 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 4 | 35.31 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.53 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 8 | 31.46 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.387 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 36 | 28.06 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.436 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 28 | 31.70 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.654 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 16 | 31.55 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.557 |
| Cohort 2 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 20 | 26.87 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.629 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 Plus 2 Days | 22.82 cells per cubic millimeter (cells/mm^3) | Standard Deviation 17.385 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 8 | 29.64 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.204 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 12 | 30.98 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.476 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 25 | 35.42 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.854 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 2 | 33.31 cells per cubic millimeter (cells/mm^3) | Standard Deviation 4.862 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 44 | 29.83 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.774 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 28 | 29.71 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.051 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 | 31.33 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.406 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 1 Day 2 | 19.51 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.129 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 20 | 34.25 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.928 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 16 | 19.19 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.466 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 48 | 21.90 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.779 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 4 | 31.47 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.658 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Baseline | 24.34 cells per cubic millimeter (cells/mm^3) | Standard Deviation 12.877 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 40 | 28.45 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.497 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 36 | 37.56 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.664 |
| Cohort 3 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 3 Day 15 | 22.60 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.766 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 3 Day 15 | 27.68 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.656 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 12 | 27.71 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.209 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Baseline | 25.75 cells per cubic millimeter (cells/mm^3) | Standard Deviation 6.874 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 1 Day 2 | 16.98 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.624 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 2 | 36.51 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.289 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 4 | 30.97 cells per cubic millimeter (cells/mm^3) | Standard Deviation 12.84 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 8 | 30.95 cells per cubic millimeter (cells/mm^3) | Standard Deviation 14.625 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 16 | 31.27 cells per cubic millimeter (cells/mm^3) | Standard Deviation 12.131 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 20 | 33.56 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.537 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 | 29.12 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.006 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 Plus 2 Days | 36.47 cells per cubic millimeter (cells/mm^3) | Standard Deviation 12.548 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 25 | 28.46 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.801 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 28 | 23.57 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.565 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 36 | 22.86 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.413 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 40 | 28.10 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.464 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 44 | 17.17 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.92 |
| Cohort 4 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 48 | 22.60 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.935 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 28 | 23.09 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.855 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 3 Day 15 | 19.88 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.902 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 16 | 27.37 cells per cubic millimeter (cells/mm^3) | Standard Deviation 14.733 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 40 | 18.17 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.192 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 25 | 27.96 cells per cubic millimeter (cells/mm^3) | Standard Deviation 6.024 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 8 | 27.73 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.162 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 2 | 28.50 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.173 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 12 | 28.03 cells per cubic millimeter (cells/mm^3) | Standard Deviation 12.045 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 48 | 30.85 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.016 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 44 | 26.22 cells per cubic millimeter (cells/mm^3) | Standard Deviation 14.34 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Baseline | 22.70 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.488 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 | 26.71 cells per cubic millimeter (cells/mm^3) | Standard Deviation 9.603 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 36 | 14.73 cells per cubic millimeter (cells/mm^3) | Standard Deviation 5.916 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 Plus 2 Days | 23.59 cells per cubic millimeter (cells/mm^3) | Standard Deviation 6.912 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 1 Day 2 | 16.49 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.985 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 4 | 24.62 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.087 |
| Cohort 5 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 20 | 27.17 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.908 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 3 Day 15 | 24.57 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.08 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 25 | 17.57 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.438 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 12 | 24.09 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.087 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Baseline | 22.27 cells per cubic millimeter (cells/mm^3) | Standard Deviation 10.588 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 28 | 21.64 cells per cubic millimeter (cells/mm^3) | Standard Deviation 14.61 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 8 | 24.59 cells per cubic millimeter (cells/mm^3) | Standard Deviation 4.511 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 4 | 27.59 cells per cubic millimeter (cells/mm^3) | Standard Deviation 11.016 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 36 | 28.20 cells per cubic millimeter (cells/mm^3) | Standard Deviation 15.386 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 16 | 17.85 cells per cubic millimeter (cells/mm^3) | Standard Deviation 4.155 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 48 | 27.03 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.844 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 40 | 26.68 cells per cubic millimeter (cells/mm^3) | Standard Deviation 17.744 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 2 | 25.69 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.761 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 1 Day 2 | 14.15 cells per cubic millimeter (cells/mm^3) | Standard Deviation 5.911 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 | 17.41 cells per cubic millimeter (cells/mm^3) | Standard Deviation 7.523 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 44 | 28.24 cells per cubic millimeter (cells/mm^3) | Standard Deviation 12.19 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 24 Plus 2 Days | 21.22 cells per cubic millimeter (cells/mm^3) | Standard Deviation 8.474 |
| Cohort 6 | Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) | Week 20 | 24.51 cells per cubic millimeter (cells/mm^3) | Standard Deviation 13.149 |
Secondary
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
A blood sample was collected and was sent to the laboratory for analysis of CD8+.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Population: ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 36 | 12.92 cells/mm^3 | Standard Deviation 7.721 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 40 | 14.63 cells/mm^3 | Standard Deviation 3.687 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 | 15.83 cells/mm^3 | Standard Deviation 4.047 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 2 | 17.03 cells/mm^3 | Standard Deviation 3.654 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Baseline | 16.80 cells/mm^3 | Standard Deviation 5.324 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 48 | 13.28 cells/mm^3 | Standard Deviation 6.673 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 4 | 13.89 cells/mm^3 | Standard Deviation 5.715 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 8 | 15.92 cells/mm^3 | Standard Deviation 8.489 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 Plus 2 Days | 14.70 cells/mm^3 | Standard Deviation 3.655 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 3 Day 15 | 12.14 cells/mm^3 | Standard Deviation 6.646 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 16 | 16.25 cells/mm^3 | Standard Deviation 6.951 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 44 | 14.41 cells/mm^3 | Standard Deviation 6.085 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 12 | 15.21 cells/mm^3 | Standard Deviation 8.122 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 1 Day 2 | 10.04 cells/mm^3 | Standard Deviation 6.698 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 25 | 15.38 cells/mm^3 | Standard Deviation 6.717 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 28 | 11.15 cells/mm^3 | Standard Deviation 4.599 |
| Cohort 1 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 20 | 15.04 cells/mm^3 | Standard Deviation 7.197 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 1 Day 2 | 12.06 cells/mm^3 | Standard Deviation 6.524 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 12 | 17.21 cells/mm^3 | Standard Deviation 6.807 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 28 | 12.84 cells/mm^3 | Standard Deviation 5.522 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 4 | 14.89 cells/mm^3 | Standard Deviation 7.815 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 36 | 11.95 cells/mm^3 | Standard Deviation 5.493 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 2 | 16.96 cells/mm^3 | Standard Deviation 7.869 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 16 | 13.87 cells/mm^3 | Standard Deviation 7.431 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 20 | 10.35 cells/mm^3 | Standard Deviation 5.998 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 48 | 12.79 cells/mm^3 | Standard Deviation 5.232 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 40 | 12.77 cells/mm^3 | Standard Deviation 7.654 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 8 | 13.91 cells/mm^3 | Standard Deviation 5.074 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 | 13.77 cells/mm^3 | Standard Deviation 5.509 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 44 | 11.46 cells/mm^3 | Standard Deviation 2.451 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 Plus 2 Days | 13.28 cells/mm^3 | Standard Deviation 6.727 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 3 Day 15 | 11.88 cells/mm^3 | Standard Deviation 6.58 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Baseline | 17.50 cells/mm^3 | Standard Deviation 5.222 |
| Cohort 2 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 25 | 12.48 cells/mm^3 | Standard Deviation 4.475 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 40 | 9.82 cells/mm^3 | Standard Deviation 3.926 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Baseline | 9.97 cells/mm^3 | Standard Deviation 4.877 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 8 | 10.97 cells/mm^3 | Standard Deviation 3.012 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 1 Day 2 | 6.87 cells/mm^3 | Standard Deviation 2.746 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 2 | 13.22 cells/mm^3 | Standard Deviation 3.141 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 20 | 10.04 cells/mm^3 | Standard Deviation 3.132 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 12 | 11.83 cells/mm^3 | Standard Deviation 5.397 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 | 11.59 cells/mm^3 | Standard Deviation 5.417 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 Plus 2 Days | 7.05 cells/mm^3 | Standard Deviation 4.656 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 25 | 12.07 cells/mm^3 | Standard Deviation 4.773 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 4 | 11.78 cells/mm^3 | Standard Deviation 3.263 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 28 | 10.63 cells/mm^3 | Standard Deviation 6.617 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 36 | 12.46 cells/mm^3 | Standard Deviation 2.84 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 16 | 6.76 cells/mm^3 | Standard Deviation 3.613 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 44 | 9.91 cells/mm^3 | Standard Deviation 3.937 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 3 Day 15 | 9.21 cells/mm^3 | Standard Deviation 4.78 |
| Cohort 3 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 48 | 7.42 cells/mm^3 | Standard Deviation 2.276 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 4 | 13.70 cells/mm^3 | Standard Deviation 5.296 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 40 | 11.59 cells/mm^3 | Standard Deviation 4.485 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 48 | 9.86 cells/mm^3 | Standard Deviation 5.26 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 3 Day 15 | 12.10 cells/mm^3 | Standard Deviation 6.033 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 Plus 2 Days | 15.52 cells/mm^3 | Standard Deviation 5.839 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 12 | 11.06 cells/mm^3 | Standard Deviation 3.773 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 2 | 14.68 cells/mm^3 | Standard Deviation 2.377 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 44 | 8.67 cells/mm^3 | Standard Deviation 5.073 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 16 | 12.51 cells/mm^3 | Standard Deviation 3.827 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 1 Day 2 | 5.93 cells/mm^3 | Standard Deviation 2.748 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 | 12.22 cells/mm^3 | Standard Deviation 5.372 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 20 | 13.71 cells/mm^3 | Standard Deviation 3.45 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Baseline | 12.25 cells/mm^3 | Standard Deviation 2.374 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 36 | 10.11 cells/mm^3 | Standard Deviation 4.527 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 28 | 11.02 cells/mm^3 | Standard Deviation 3.03 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 8 | 12.80 cells/mm^3 | Standard Deviation 7.567 |
| Cohort 4 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 25 | 11.60 cells/mm^3 | Standard Deviation 4.172 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 8 | 9.63 cells/mm^3 | Standard Deviation 3.056 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 12 | 8.93 cells/mm^3 | Standard Deviation 4.185 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 16 | 10.63 cells/mm^3 | Standard Deviation 6.203 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 20 | 10.29 cells/mm^3 | Standard Deviation 5.15 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 | 12.05 cells/mm^3 | Standard Deviation 6.859 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 Plus 2 Days | 8.90 cells/mm^3 | Standard Deviation 1.508 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 25 | 9.78 cells/mm^3 | Standard Deviation 2.395 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 28 | 9.32 cells/mm^3 | Standard Deviation 2.121 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 36 | 6.92 cells/mm^3 | Standard Deviation 3.158 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 40 | 7.93 cells/mm^3 | Standard Deviation 2.207 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 44 | 9.59 cells/mm^3 | Standard Deviation 3.922 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 48 | 11.68 cells/mm^3 | Standard Deviation 5.757 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Baseline | 8.72 cells/mm^3 | Standard Deviation 3.59 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 1 Day 2 | 5.14 cells/mm^3 | Standard Deviation 2.779 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 2 | 11.14 cells/mm^3 | Standard Deviation 4.767 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 3 Day 15 | 7.22 cells/mm^3 | Standard Deviation 4.103 |
| Cohort 5 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 4 | 9.89 cells/mm^3 | Standard Deviation 2.12 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Baseline | 12.83 cells/mm^3 | Standard Deviation 6.576 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 48 | 13.50 cells/mm^3 | Standard Deviation 3.412 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 44 | 11.87 cells/mm^3 | Standard Deviation 3.352 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 40 | 10.30 cells/mm^3 | Standard Deviation 4.027 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 12 | 14.87 cells/mm^3 | Standard Deviation 9.608 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 3 Day 15 | 12.50 cells/mm^3 | Standard Deviation 6.536 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 36 | 11.59 cells/mm^3 | Standard Deviation 2.584 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 28 | 9.71 cells/mm^3 | Standard Deviation 3.16 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 25 | 8.94 cells/mm^3 | Standard Deviation 6.287 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 Plus 2 Days | 9.41 cells/mm^3 | Standard Deviation 3.298 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 8 | 12.62 cells/mm^3 | Standard Deviation 5.613 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 4 | 13.49 cells/mm^3 | Standard Deviation 5.214 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 24 | 9.45 cells/mm^3 | Standard Deviation 6.093 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 20 | 12.98 cells/mm^3 | Standard Deviation 7.476 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 1 Day 2 | 7.61 cells/mm^3 | Standard Deviation 5.157 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 16 | 10.86 cells/mm^3 | Standard Deviation 5.193 |
| Cohort 6 | Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) | Week 2 | 14.22 cells/mm^3 | Standard Deviation 9.157 |
Secondary
Additional Immune Profiling-Interleukin 10 (IL10)
A blood sample was collected and was sent to the laboratory for analysis of IL-10. IL-10 is an anti-inflammatory cytokine that maintains the balance of the immune response, allowing the clearance of infection while minimizing damage to the host.
Time frame: Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48
Population: ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 24 | 0.43 picogram per milliliter (pg/ml) | Standard Deviation 0.454 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 36 | 0.21 picogram per milliliter (pg/ml) | Standard Deviation 0.124 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 4 | 0.53 picogram per milliliter (pg/ml) | Standard Deviation 0.294 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 2 | 0.39 picogram per milliliter (pg/ml) | Standard Deviation 0.258 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 25 | 0.32 picogram per milliliter (pg/ml) | Standard Deviation 0.163 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Baseline | 0.25 picogram per milliliter (pg/ml) | Standard Deviation 0.175 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 20 | 0.24 picogram per milliliter (pg/ml) | Standard Deviation 0.16 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 44 | 0.15 picogram per milliliter (pg/ml) | Standard Deviation 0.164 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 12 | 0.57 picogram per milliliter (pg/ml) | Standard Deviation 0.599 |
| Cohort 1 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 48 | 0.07 picogram per milliliter (pg/ml) | Standard Deviation 0.063 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 12 | 0.89 picogram per milliliter (pg/ml) | Standard Deviation 1.223 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 20 | 0.65 picogram per milliliter (pg/ml) | Standard Deviation 0.631 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 44 | 0.35 picogram per milliliter (pg/ml) | Standard Deviation 0.715 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 2 | 0.39 picogram per milliliter (pg/ml) | Standard Deviation 0.35 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Baseline | 0.37 picogram per milliliter (pg/ml) | Standard Deviation 0.343 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 36 | 0.36 picogram per milliliter (pg/ml) | Standard Deviation 0.543 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 4 | 0.42 picogram per milliliter (pg/ml) | Standard Deviation 0.29 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 48 | 0.44 picogram per milliliter (pg/ml) | Standard Deviation 0.551 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 24 | 0.45 picogram per milliliter (pg/ml) | Standard Deviation 0.363 |
| Cohort 2 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 25 | 0.40 picogram per milliliter (pg/ml) | Standard Deviation 0.237 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 24 | 0.49 picogram per milliliter (pg/ml) | Standard Deviation 0.635 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Baseline | 0.41 picogram per milliliter (pg/ml) | Standard Deviation 0.459 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 2 | 0.27 picogram per milliliter (pg/ml) | Standard Deviation 0.184 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 4 | 0.40 picogram per milliliter (pg/ml) | Standard Deviation 0.286 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 12 | 0.70 picogram per milliliter (pg/ml) | Standard Deviation 0.783 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 20 | 0.24 picogram per milliliter (pg/ml) | Standard Deviation 0.141 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 25 | 0.18 picogram per milliliter (pg/ml) | Standard Deviation 0.292 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 36 | 0.08 picogram per milliliter (pg/ml) | Standard Deviation 0.068 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 44 | 2.77 picogram per milliliter (pg/ml) | Standard Deviation 3.101 |
| Cohort 3 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 48 | 1.87 picogram per milliliter (pg/ml) | Standard Deviation 1.465 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 20 | 0.13 picogram per milliliter (pg/ml) | Standard Deviation 0.213 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 2 | 0.42 picogram per milliliter (pg/ml) | Standard Deviation 0.07 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 36 | 0.79 picogram per milliliter (pg/ml) | Standard Deviation 0.769 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 12 | 0.26 picogram per milliliter (pg/ml) | Standard Deviation 0.422 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 48 | 3.13 picogram per milliliter (pg/ml) | Standard Deviation 5.552 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Baseline | 0.40 picogram per milliliter (pg/ml) | Standard Deviation 0.247 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 24 | 0.29 picogram per milliliter (pg/ml) | Standard Deviation 0.325 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 4 | 0.34 picogram per milliliter (pg/ml) | Standard Deviation 0.135 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 44 | 1.25 picogram per milliliter (pg/ml) | Standard Deviation 1.268 |
| Cohort 4 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 25 | 0.24 picogram per milliliter (pg/ml) | Standard Deviation 0.237 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 12 | 0.04 picogram per milliliter (pg/ml) | Standard Deviation 0.028 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 24 | 2.14 picogram per milliliter (pg/ml) | Standard Deviation 3.329 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 4 | 0.62 picogram per milliliter (pg/ml) | Standard Deviation 1.059 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 25 | 1.31 picogram per milliliter (pg/ml) | Standard Deviation 1.168 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 2 | 0.16 picogram per milliliter (pg/ml) | Standard Deviation 0.143 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 36 | 0.95 picogram per milliliter (pg/ml) | Standard Deviation 0.535 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 48 | 0.68 picogram per milliliter (pg/ml) | Standard Deviation 0.773 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 44 | 0.65 picogram per milliliter (pg/ml) | Standard Deviation 0.452 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Baseline | 0.13 picogram per milliliter (pg/ml) | Standard Deviation 0.129 |
| Cohort 5 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 20 | 0.57 picogram per milliliter (pg/ml) | Standard Deviation 0.467 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 4 | 0.25 picogram per milliliter (pg/ml) | Standard Deviation 0.358 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 48 | 1.23 picogram per milliliter (pg/ml) | Standard Deviation 0.568 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 24 | 0.91 picogram per milliliter (pg/ml) | Standard Deviation 0.778 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 44 | 2.11 picogram per milliliter (pg/ml) | Standard Deviation 1.533 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 20 | 0.64 picogram per milliliter (pg/ml) | Standard Deviation 0.593 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 2 | 0.07 picogram per milliliter (pg/ml) | Standard Deviation 0.12 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 12 | 1.19 picogram per milliliter (pg/ml) | Standard Deviation 1.147 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 36 | 0.82 picogram per milliliter (pg/ml) | Standard Deviation 0.303 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Week 25 | 1.36 picogram per milliliter (pg/ml) | Standard Deviation 0.922 |
| Cohort 6 | Additional Immune Profiling-Interleukin 10 (IL10) | Baseline | 0.09 picogram per milliliter (pg/ml) | Standard Deviation 0.12 |
Secondary
Additional Immune Profiling-Natural Killer (NK) Cells
A blood sample was collected and was sent to the laboratory for analysis of NK cells. Percentage of NK cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Population: ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 44 | 7.20 percentage of cells/mL | Standard Deviation 7.764 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 3 Day 15 | 4.99 percentage of cells/mL | Standard Deviation 1.647 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Baseline | 6.53 percentage of cells/mL | Standard Deviation 2.829 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 36 | 6.63 percentage of cells/mL | Standard Deviation 3.648 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 1 Day 2 | 1.98 percentage of cells/mL | Standard Deviation 1.597 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 8 | 6.22 percentage of cells/mL | Standard Deviation 4.761 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 28 | 8.06 percentage of cells/mL | Standard Deviation 7.674 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 4 | 6.45 percentage of cells/mL | Standard Deviation 3.189 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 Plus 2 Days | 8.31 percentage of cells/mL | Standard Deviation 9.513 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 40 | 9.17 percentage of cells/mL | Standard Deviation 4.527 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 | 6.70 percentage of cells/mL | Standard Deviation 4.883 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 16 | 10.49 percentage of cells/mL | Standard Deviation 5.747 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 2 | 7.34 percentage of cells/mL | Standard Deviation 6.862 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 25 | 11.45 percentage of cells/mL | Standard Deviation 6.599 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 12 | 5.47 percentage of cells/mL | Standard Deviation 2.114 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 20 | 10.17 percentage of cells/mL | Standard Deviation 7.791 |
| Cohort 1 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 48 | 3.84 percentage of cells/mL | Standard Deviation 2.081 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 8 | 7.53 percentage of cells/mL | Standard Deviation 4.347 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 25 | 6.56 percentage of cells/mL | Standard Deviation 4.849 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 | 6.51 percentage of cells/mL | Standard Deviation 3.781 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 Plus 2 Days | 4.45 percentage of cells/mL | Standard Deviation 4.072 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 2 | 6.03 percentage of cells/mL | Standard Deviation 5.001 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Baseline | 7.22 percentage of cells/mL | Standard Deviation 4.469 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 44 | 4.40 percentage of cells/mL | Standard Deviation 3.481 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 3 Day 15 | 6.62 percentage of cells/mL | Standard Deviation 5.84 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 40 | 4.67 percentage of cells/mL | Standard Deviation 3.109 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 4 | 7.88 percentage of cells/mL | Standard Deviation 8.131 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 48 | 5.23 percentage of cells/mL | Standard Deviation 4.943 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 36 | 6.36 percentage of cells/mL | Standard Deviation 7.256 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 12 | 6.33 percentage of cells/mL | Standard Deviation 3.053 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 1 Day 2 | 2.01 percentage of cells/mL | Standard Deviation 2.465 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 28 | 5.47 percentage of cells/mL | Standard Deviation 4.326 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 16 | 5.28 percentage of cells/mL | Standard Deviation 2.548 |
| Cohort 2 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 20 | 4.46 percentage of cells/mL | Standard Deviation 2.638 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 1 Day 2 | 2.11 percentage of cells/mL | Standard Deviation 1.386 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 3 Day 15 | 5.63 percentage of cells/mL | Standard Deviation 2.792 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 2 | 6.27 percentage of cells/mL | Standard Deviation 1.23 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 Plus 2 Days | 3.75 percentage of cells/mL | Standard Deviation 2.422 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 12 | 6.71 percentage of cells/mL | Standard Deviation 2.328 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 25 | 5.91 percentage of cells/mL | Standard Deviation 3.133 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 28 | 5.69 percentage of cells/mL | Standard Deviation 3.218 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 | 5.84 percentage of cells/mL | Standard Deviation 2.89 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 44 | 5.00 percentage of cells/mL | Standard Deviation 1.733 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 20 | 6.81 percentage of cells/mL | Standard Deviation 4.994 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 16 | 5.91 percentage of cells/mL | Standard Deviation 3.136 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 4 | 7.49 percentage of cells/mL | Standard Deviation 2.242 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 36 | 5.72 percentage of cells/mL | Standard Deviation 1.275 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 40 | 5.20 percentage of cells/mL | Standard Deviation 2.904 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Baseline | 5.06 percentage of cells/mL | Standard Deviation 2.618 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 8 | 6.79 percentage of cells/mL | Standard Deviation 4.172 |
| Cohort 3 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 48 | 6.72 percentage of cells/mL | Standard Deviation 1.96 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 Plus 2 Days | 3.38 percentage of cells/mL | Standard Deviation 1.684 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Baseline | 7.68 percentage of cells/mL | Standard Deviation 3.724 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 1 Day 2 | 1.38 percentage of cells/mL | Standard Deviation 0.68 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 2 | 7.93 percentage of cells/mL | Standard Deviation 2.861 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 3 Day 15 | 5.93 percentage of cells/mL | Standard Deviation 4.679 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 4 | 5.72 percentage of cells/mL | Standard Deviation 2.458 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 8 | 4.80 percentage of cells/mL | Standard Deviation 2.463 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 12 | 5.25 percentage of cells/mL | Standard Deviation 2.494 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 16 | 5.34 percentage of cells/mL | Standard Deviation 3.057 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 20 | 5.73 percentage of cells/mL | Standard Deviation 2.105 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 | 4.55 percentage of cells/mL | Standard Deviation 2.243 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 25 | 3.71 percentage of cells/mL | Standard Deviation 2.199 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 28 | 4.73 percentage of cells/mL | Standard Deviation 3.334 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 36 | 7.88 percentage of cells/mL | Standard Deviation 5.515 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 40 | 6.18 percentage of cells/mL | Standard Deviation 2.901 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 44 | 8.97 percentage of cells/mL | Standard Deviation 6.008 |
| Cohort 4 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 48 | 6.94 percentage of cells/mL | Standard Deviation 3.601 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 28 | 8.29 percentage of cells/mL | Standard Deviation 5.664 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 3 Day 15 | 3.50 percentage of cells/mL | Standard Deviation 1.717 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 16 | 5.58 percentage of cells/mL | Standard Deviation 4.578 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 40 | 6.64 percentage of cells/mL | Standard Deviation 3.07 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 25 | 6.51 percentage of cells/mL | Standard Deviation 3.541 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 8 | 4.81 percentage of cells/mL | Standard Deviation 2.573 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 2 | 6.17 percentage of cells/mL | Standard Deviation 3.588 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 12 | 3.46 percentage of cells/mL | Standard Deviation 1.469 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 48 | 7.05 percentage of cells/mL | Standard Deviation 4.446 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 44 | 6.59 percentage of cells/mL | Standard Deviation 4.777 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Baseline | 5.04 percentage of cells/mL | Standard Deviation 2.719 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 36 | 8.22 percentage of cells/mL | Standard Deviation 5.772 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 | 8.51 percentage of cells/mL | Standard Deviation 5.484 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 Plus 2 Days | 5.83 percentage of cells/mL | Standard Deviation 3.711 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 1 Day 2 | 1.10 percentage of cells/mL | Standard Deviation 0.372 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 4 | 6.12 percentage of cells/mL | Standard Deviation 5.44 |
| Cohort 5 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 20 | 5.79 percentage of cells/mL | Standard Deviation 3.144 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 3 Day 15 | 4.40 percentage of cells/mL | Standard Deviation 2.57 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 25 | 8.34 percentage of cells/mL | Standard Deviation 5.602 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 12 | 5.71 percentage of cells/mL | Standard Deviation 2.446 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Baseline | 4.67 percentage of cells/mL | Standard Deviation 1.946 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 28 | 6.95 percentage of cells/mL | Standard Deviation 2.97 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 8 | 6.21 percentage of cells/mL | Standard Deviation 4.52 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 4 | 4.80 percentage of cells/mL | Standard Deviation 3.352 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 36 | 9.58 percentage of cells/mL | Standard Deviation 7.535 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 16 | 7.34 percentage of cells/mL | Standard Deviation 6.747 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 48 | 6.10 percentage of cells/mL | Standard Deviation 1.93 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 40 | 6.90 percentage of cells/mL | Standard Deviation 3.244 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 2 | 4.09 percentage of cells/mL | Standard Deviation 1.92 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 1 Day 2 | 1.08 percentage of cells/mL | Standard Deviation 0.98 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 44 | 7.14 percentage of cells/mL | Standard Deviation 3.195 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 | 9.81 percentage of cells/mL | Standard Deviation 3.968 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 24 Plus 2 Days | 4.97 percentage of cells/mL | Standard Deviation 1.11 |
| Cohort 6 | Additional Immune Profiling-Natural Killer (NK) Cells | Week 20 | 8.03 percentage of cells/mL | Standard Deviation 7.391 |
Secondary
Annualized Relapse Rate (ARR)
ARR at Week 48 is calculated as the ratio of the sum of all participants confirmed relapse counts divided by the sum of all participants treatment duration (in years).
Time frame: Week 48
Population: ITT population included all participants who received at least one dose of ublituximab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Annualized Relapse Rate (ARR) | 0.28 relapses per participant-years |
| Cohort 2 | Annualized Relapse Rate (ARR) | 0.00 relapses per participant-years |
| Cohort 3 | Annualized Relapse Rate (ARR) | 0.14 relapses per participant-years |
| Cohort 4 | Annualized Relapse Rate (ARR) | 0.14 relapses per participant-years |
| Cohort 5 | Annualized Relapse Rate (ARR) | 0.00 relapses per participant-years |
| Cohort 6 | Annualized Relapse Rate (ARR) | 0.00 relapses per participant-years |
Secondary
Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells
Cluster of Differentiation (CD)19 is a marker of B cells, the protein has been used to diagnose cancers that arise from this type of cell - notably B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The majority of B cell malignancies express normal to high levels of CD19. Memory B cell is a type of B lymphocyte that forms part of the adaptive immune system. These cells develop within germinal centers of the secondary lymphoid organs. Their function is to memorize the characteristics of the antigen that activated their parent B cell during initial infection such that if the memory B cell later encounters the same antigen, it triggers an accelerated and robust secondary immune response. A naive B cell is a B cell that has not been exposed to an antigen. Once exposed to an antigen, the naive B cell either becomes a memory B cell or a plasma cell that secretes antibodies specific to the antigen that was originally bound.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 plus 2 days, Weeks 25, 28, 36, 40, 44 and 48
Population: ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 44 | -6.89 percentage of cells | Standard Deviation 3.831 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Baseline | 0.38 percentage of cells | Standard Deviation 0.337 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 40 | -5.18 percentage of cells | Standard Deviation 3.74 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 25 | -6.13 percentage of cells | Standard Deviation 3.473 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 | -7.21 percentage of cells | Standard Deviation 4.068 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 4 | -7.28 percentage of cells | Standard Deviation 4.127 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 12 | -7.00 percentage of cells | Standard Deviation 4.287 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 44 | -0.34 percentage of cells | Standard Deviation 0.341 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 48 | -7.25 percentage of cells | Standard Deviation 4.086 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 28 | -0.34 percentage of cells | Standard Deviation 0.336 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days | -7.31 percentage of cells | Standard Deviation 4.108 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 16 | -0.30 percentage of cells | Standard Deviation 0.355 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 44 | -7.32 percentage of cells | Standard Deviation 4.092 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 48 | -6.83 percentage of cells | Standard Deviation 3.809 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days | -6.87 percentage of cells | Standard Deviation 3.842 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 16 | -6.61 percentage of cells | Standard Deviation 4.067 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 25 | -6.45 percentage of cells | Standard Deviation 3.698 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Baseline | 7.40 percentage of cells | Standard Deviation 4.108 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 40 | -5.40 percentage of cells | Standard Deviation 3.828 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 20 | -6.87 percentage of cells | Standard Deviation 3.828 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 4 | -0.31 percentage of cells | Standard Deviation 0.347 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 | -6.81 percentage of cells | Standard Deviation 3.788 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 28 | -7.31 percentage of cells | Standard Deviation 4.106 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15 | -6.86 percentage of cells | Standard Deviation 3.805 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 36 | -7.32 percentage of cells | Standard Deviation 4.082 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 2 | -7.52 percentage of cells | Standard Deviation 3.175 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 | -0.30 percentage of cells | Standard Deviation 0.34 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 36 | -0.34 percentage of cells | Standard Deviation 0.322 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days | -0.34 percentage of cells | Standard Deviation 0.33 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15 | -0.31 percentage of cells | Standard Deviation 0.285 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 8 | -7.29 percentage of cells | Standard Deviation 4.102 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 40 | -0.20 percentage of cells | Standard Deviation 0.086 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Baseline | 6.92 percentage of cells | Standard Deviation 3.837 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 4 | -6.87 percentage of cells | Standard Deviation 3.836 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2 | -6.18 percentage of cells | Standard Deviation 3.665 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 12 | -0.36 percentage of cells | Standard Deviation 0.364 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 36 | -6.89 percentage of cells | Standard Deviation 3.83 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 12 | -7.47 percentage of cells | Standard Deviation 4.592 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 48 | -0.32 percentage of cells | Standard Deviation 0.344 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 2 | -0.32 percentage of cells | Standard Deviation 0.354 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 1 Day 2 | -6.55 percentage of cells | Standard Deviation 3.92 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 3 Day 15 | -7.27 percentage of cells | Standard Deviation 4.053 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 2 | -7.09 percentage of cells | Standard Deviation 2.899 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 16 | -7.01 percentage of cells | Standard Deviation 4.352 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 25 | -0.28 percentage of cells | Standard Deviation 0.371 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2 | -0.28 percentage of cells | Standard Deviation 0.279 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 20 | -0.27 percentage of cells | Standard Deviation 0.335 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 28 | -6.87 percentage of cells | Standard Deviation 3.837 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 8 | -6.88 percentage of cells | Standard Deviation 3.831 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 20 | -7.23 percentage of cells | Standard Deviation 4.116 |
| Cohort 1 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 8 | -0.32 percentage of cells | Standard Deviation 0.331 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 12 | -7.77 percentage of cells | Standard Deviation 3.823 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Baseline | 7.30 percentage of cells | Standard Deviation 3.188 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 | -0.84 percentage of cells | Standard Deviation 0.656 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 48 | -0.65 percentage of cells | Standard Deviation 0.463 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days | -0.74 percentage of cells | Standard Deviation 0.434 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 25 | -0.97 percentage of cells | Standard Deviation 0.738 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 44 | -0.66 percentage of cells | Standard Deviation 0.429 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 28 | -0.68 percentage of cells | Standard Deviation 0.442 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 40 | -0.68 percentage of cells | Standard Deviation 0.441 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 36 | -0.68 percentage of cells | Standard Deviation 0.436 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 8 | -7.79 percentage of cells | Standard Deviation 3.886 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 48 | -6.46 percentage of cells | Standard Deviation 2.58 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 36 | -6.52 percentage of cells | Standard Deviation 2.594 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 4 | -7.79 percentage of cells | Standard Deviation 3.859 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 28 | -6.53 percentage of cells | Standard Deviation 2.612 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 16 | -7.53 percentage of cells | Standard Deviation 4.11 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 1 Day 2 | -8.29 percentage of cells | Standard Deviation 3.85 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 20 | -8.07 percentage of cells | Standard Deviation 4.449 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 25 | -7.61 percentage of cells | Standard Deviation 3.257 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 | -7.53 percentage of cells | Standard Deviation 3.399 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Baseline | 7.89 percentage of cells | Standard Deviation 3.899 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days | -6.18 percentage of cells | Standard Deviation 2.666 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days | -6.45 percentage of cells | Standard Deviation 2.919 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 25 | -8.20 percentage of cells | Standard Deviation 4.007 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 | -7.02 percentage of cells | Standard Deviation 2.809 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 28 | -6.81 percentage of cells | Standard Deviation 2.844 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 20 | -7.67 percentage of cells | Standard Deviation 3.234 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 36 | -6.79 percentage of cells | Standard Deviation 2.82 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 2 | -7.80 percentage of cells | Standard Deviation 3.878 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 40 | -6.74 percentage of cells | Standard Deviation 2.838 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 16 | -7.00 percentage of cells | Standard Deviation 3.341 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 44 | -6.74 percentage of cells | Standard Deviation 2.801 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 12 | -7.26 percentage of cells | Standard Deviation 3.175 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 48 | -6.71 percentage of cells | Standard Deviation 2.854 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 44 | -6.48 percentage of cells | Standard Deviation 2.573 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Baseline | 0.92 percentage of cells | Standard Deviation 0.722 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 8 | -7.26 percentage of cells | Standard Deviation 3.173 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2 | -0.92 percentage of cells | Standard Deviation 0.728 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 4 | -7.26 percentage of cells | Standard Deviation 3.173 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 2 | -0.86 percentage of cells | Standard Deviation 0.713 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 3 Day 15 | -7.80 percentage of cells | Standard Deviation 3.83 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15 | -0.86 percentage of cells | Standard Deviation 0.694 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15 | -7.27 percentage of cells | Standard Deviation 3.161 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 4 | -0.85 percentage of cells | Standard Deviation 0.69 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 2 | -7.27 percentage of cells | Standard Deviation 3.177 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 8 | -0.86 percentage of cells | Standard Deviation 0.736 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 12 | -0.83 percentage of cells | Standard Deviation 0.668 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 40 | -6.46 percentage of cells | Standard Deviation 2.565 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2 | -7.29 percentage of cells | Standard Deviation 3.427 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 16 | -0.92 percentage of cells | Standard Deviation 0.769 |
| Cohort 2 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 20 | -0.86 percentage of cells | Standard Deviation 0.849 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 8 | -6.22 percentage of cells | Standard Deviation 4.057 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 1 Day 2 | -6.54 percentage of cells | Standard Deviation 4.715 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 44 | -0.85 percentage of cells | Standard Deviation 0.997 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Baseline | 0.90 percentage of cells | Standard Deviation 1.01 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 20 | -7.18 percentage of cells | Standard Deviation 4.637 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2 | -5.56 percentage of cells | Standard Deviation 3.954 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 25 | -6.81 percentage of cells | Standard Deviation 4.012 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 16 | -7.75 percentage of cells | Standard Deviation 4.628 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 48 | -5.96 percentage of cells | Standard Deviation 4.091 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2 | -0.90 percentage of cells | Standard Deviation 1.098 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 28 | -6.24 percentage of cells | Standard Deviation 4.047 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 4 | -6.13 percentage of cells | Standard Deviation 4.342 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 4 | -6.82 percentage of cells | Standard Deviation 4.889 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 12 | -7.17 percentage of cells | Standard Deviation 4.617 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 12 | -0.87 percentage of cells | Standard Deviation 1.019 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 2 | -0.83 percentage of cells | Standard Deviation 1.032 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Baseline | 6.26 percentage of cells | Standard Deviation 4.043 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 8 | -7.15 percentage of cells | Standard Deviation 4.625 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15 | -6.23 percentage of cells | Standard Deviation 4.043 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 36 | -0.87 percentage of cells | Standard Deviation 1.02 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 | -0.96 percentage of cells | Standard Deviation 1.038 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15 | -0.86 percentage of cells | Standard Deviation 1.007 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 3 Day 15 | -7.17 percentage of cells | Standard Deviation 4.592 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days | -0.76 percentage of cells | Standard Deviation 0.875 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 40 | -0.86 percentage of cells | Standard Deviation 1.012 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 36 | -6.23 percentage of cells | Standard Deviation 4.051 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 20 | -6.02 percentage of cells | Standard Deviation 3.994 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 48 | -0.83 percentage of cells | Standard Deviation 0.983 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 28 | -7.18 percentage of cells | Standard Deviation 4.597 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 4 | -0.64 percentage of cells | Standard Deviation 0.91 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 36 | -7.18 percentage of cells | Standard Deviation 4.601 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 28 | -0.87 percentage of cells | Standard Deviation 1.021 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 44 | -6.13 percentage of cells | Standard Deviation 4.05 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 16 | -6.74 percentage of cells | Standard Deviation 4.085 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 25 | -7.88 percentage of cells | Standard Deviation 4.512 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 2 | -6.23 percentage of cells | Standard Deviation 4.058 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 40 | -7.15 percentage of cells | Standard Deviation 4.567 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 2 | -7.13 percentage of cells | Standard Deviation 4.617 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 20 | -1.07 percentage of cells | Standard Deviation 1.101 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 | -6.71 percentage of cells | Standard Deviation 4.024 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days | -7.98 percentage of cells | Standard Deviation 4.43 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 25 | -0.98 percentage of cells | Standard Deviation 1.057 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 44 | -7.05 percentage of cells | Standard Deviation 4.546 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Baseline | 7.24 percentage of cells | Standard Deviation 4.586 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 12 | -6.23 percentage of cells | Standard Deviation 4.061 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 16 | -0.93 percentage of cells | Standard Deviation 1.068 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days | -7.15 percentage of cells | Standard Deviation 4.231 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 8 | -0.85 percentage of cells | Standard Deviation 1.03 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 48 | -6.87 percentage of cells | Standard Deviation 4.542 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 40 | -6.21 percentage of cells | Standard Deviation 4.042 |
| Cohort 3 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 | -7.76 percentage of cells | Standard Deviation 4.478 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days | -6.81 percentage of cells | Standard Deviation 2.272 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Baseline | 8.11 percentage of cells | Standard Deviation 2.696 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 1 Day 2 | -7.95 percentage of cells | Standard Deviation 2.719 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 2 | -6.95 percentage of cells | Standard Deviation 1.806 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 3 Day 15 | -8.03 percentage of cells | Standard Deviation 2.714 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 4 | -8.03 percentage of cells | Standard Deviation 2.717 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 8 | -8.03 percentage of cells | Standard Deviation 3.032 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 12 | -8.45 percentage of cells | Standard Deviation 2.644 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 16 | -7.83 percentage of cells | Standard Deviation 2.667 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 20 | -7.58 percentage of cells | Standard Deviation 2.74 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 | -7.39 percentage of cells | Standard Deviation 2.94 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days | -7.88 percentage of cells | Standard Deviation 2.895 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 25 | -8.06 percentage of cells | Standard Deviation 2.694 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 28 | -8.00 percentage of cells | Standard Deviation 2.699 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 36 | -8.48 percentage of cells | Standard Deviation 2.905 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 40 | -7.77 percentage of cells | Standard Deviation 3.132 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 44 | -8.06 percentage of cells | Standard Deviation 2.86 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 48 | -7.73 percentage of cells | Standard Deviation 2.621 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Baseline | 0.68 percentage of cells | Standard Deviation 0.457 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2 | -0.59 percentage of cells | Standard Deviation 0.48 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 2 | -0.46 percentage of cells | Standard Deviation 0.411 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15 | -0.63 percentage of cells | Standard Deviation 0.468 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 4 | -0.64 percentage of cells | Standard Deviation 0.465 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 8 | -0.64 percentage of cells | Standard Deviation 0.552 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 12 | -0.69 percentage of cells | Standard Deviation 0.494 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 16 | -0.65 percentage of cells | Standard Deviation 0.456 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 20 | -0.64 percentage of cells | Standard Deviation 0.431 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 | -0.69 percentage of cells | Standard Deviation 0.442 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days | -0.59 percentage of cells | Standard Deviation 0.469 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 25 | -0.65 percentage of cells | Standard Deviation 0.465 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 28 | -0.62 percentage of cells | Standard Deviation 0.508 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 36 | -0.75 percentage of cells | Standard Deviation 0.495 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 40 | -0.62 percentage of cells | Standard Deviation 0.45 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 44 | -0.69 percentage of cells | Standard Deviation 0.462 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 48 | -0.62 percentage of cells | Standard Deviation 0.433 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Baseline | 7.00 percentage of cells | Standard Deviation 2.135 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2 | -6.93 percentage of cells | Standard Deviation 2.132 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 2 | -6.18 percentage of cells | Standard Deviation 1.723 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15 | -6.97 percentage of cells | Standard Deviation 2.137 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 4 | -6.96 percentage of cells | Standard Deviation 2.134 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 8 | -6.99 percentage of cells | Standard Deviation 2.322 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 12 | -7.29 percentage of cells | Standard Deviation 2.06 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 16 | -6.76 percentage of cells | Standard Deviation 2.098 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 20 | -6.52 percentage of cells | Standard Deviation 2.214 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 | -6.26 percentage of cells | Standard Deviation 2.275 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 25 | -6.98 percentage of cells | Standard Deviation 2.132 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 28 | -6.95 percentage of cells | Standard Deviation 2.139 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 36 | -7.22 percentage of cells | Standard Deviation 2.249 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 40 | -6.63 percentage of cells | Standard Deviation 2.419 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 44 | -6.98 percentage of cells | Standard Deviation 2.283 |
| Cohort 4 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 48 | -6.69 percentage of cells | Standard Deviation 2.06 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 2 | -0.86 percentage of cells | Standard Deviation 1.003 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 20 | -0.88 percentage of cells | Standard Deviation 1.064 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 3 Day 15 | -5.69 percentage of cells | Standard Deviation 2.369 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Baseline | 4.73 percentage of cells | Standard Deviation 2.206 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 12 | -0.92 percentage of cells | Standard Deviation 1.068 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2 | -4.72 percentage of cells | Standard Deviation 2.203 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 8 | -0.87 percentage of cells | Standard Deviation 0.994 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 4 | -0.91 percentage of cells | Standard Deviation 1.072 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 40 | -4.72 percentage of cells | Standard Deviation 2.204 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 2 | -4.73 percentage of cells | Standard Deviation 2.205 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15 | -0.87 percentage of cells | Standard Deviation 1.001 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15 | -4.73 percentage of cells | Standard Deviation 2.205 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2 | -0.85 percentage of cells | Standard Deviation 1.001 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 4 | -5.02 percentage of cells | Standard Deviation 2.211 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Baseline | 0.88 percentage of cells | Standard Deviation 0.997 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 2 | -5.68 percentage of cells | Standard Deviation 2.362 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 8 | -4.73 percentage of cells | Standard Deviation 2.203 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 48 | -5.67 percentage of cells | Standard Deviation 2.342 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 44 | -5.65 percentage of cells | Standard Deviation 2.341 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 12 | -4.36 percentage of cells | Standard Deviation 2.1 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 40 | -5.65 percentage of cells | Standard Deviation 2.343 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 48 | -4.73 percentage of cells | Standard Deviation 2.205 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 16 | -4.73 percentage of cells | Standard Deviation 2.209 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 36 | -5.69 percentage of cells | Standard Deviation 2.53 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 28 | -5.65 percentage of cells | Standard Deviation 2.36 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 44 | -4.72 percentage of cells | Standard Deviation 2.204 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 20 | -4.73 percentage of cells | Standard Deviation 2.377 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 25 | -5.57 percentage of cells | Standard Deviation 2.544 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 | -4.71 percentage of cells | Standard Deviation 2.207 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days | -6.29 percentage of cells | Standard Deviation 2.403 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 | -5.65 percentage of cells | Standard Deviation 2.377 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 16 | -0.87 percentage of cells | Standard Deviation 1.004 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days | -5.28 percentage of cells | Standard Deviation 2.286 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 20 | -5.70 percentage of cells | Standard Deviation 2.534 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 1 Day 2 | -5.66 percentage of cells | Standard Deviation 2.347 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 25 | -4.52 percentage of cells | Standard Deviation 2.305 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 16 | -5.68 percentage of cells | Standard Deviation 2.375 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 12 | -5.35 percentage of cells | Standard Deviation 2.317 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 28 | -4.71 percentage of cells | Standard Deviation 2.208 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 8 | -5.69 percentage of cells | Standard Deviation 2.358 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Baseline | 5.71 percentage of cells | Standard Deviation 2.368 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 36 | -4.72 percentage of cells | Standard Deviation 2.374 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 36 | -0.88 percentage of cells | Standard Deviation 1.069 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 28 | -0.85 percentage of cells | Standard Deviation 0.971 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 40 | -0.85 percentage of cells | Standard Deviation 0.975 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 25 | -0.95 percentage of cells | Standard Deviation 1.033 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 4 | -6.03 percentage of cells | Standard Deviation 2.322 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 44 | -0.85 percentage of cells | Standard Deviation 1.008 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days | -0.91 percentage of cells | Standard Deviation 1.168 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 | -0.86 percentage of cells | Standard Deviation 1.007 |
| Cohort 5 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 48 | -0.86 percentage of cells | Standard Deviation 1.007 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 40 | -0.57 percentage of cells | Standard Deviation 0.424 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 28 | -5.97 percentage of cells | Standard Deviation 2.235 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 16 | -0.56 percentage of cells | Standard Deviation 0.427 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 20 | -6.06 percentage of cells | Standard Deviation 2.139 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 25 | -7.47 percentage of cells | Standard Deviation 2.008 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Baseline | 6.11 percentage of cells | Standard Deviation 2.096 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 12 | -0.60 percentage of cells | Standard Deviation 0.381 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 8 | -6.70 percentage of cells | Standard Deviation 2.065 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 8 | -0.55 percentage of cells | Standard Deviation 0.381 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 48 | -6.60 percentage of cells | Standard Deviation 2.292 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days | -7.47 percentage of cells | Standard Deviation 1.983 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2 | -6.09 percentage of cells | Standard Deviation 2.1 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 44 | -5.94 percentage of cells | Standard Deviation 2.248 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 4 | -0.55 percentage of cells | Standard Deviation 0.396 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 25 | -0.61 percentage of cells | Standard Deviation 0.404 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 | -4.96 percentage of cells | Standard Deviation 1.658 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 4 | -6.71 percentage of cells | Standard Deviation 2.102 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 2 | -6.10 percentage of cells | Standard Deviation 2.089 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15 | -0.57 percentage of cells | Standard Deviation 0.382 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 24 | -5.62 percentage of cells | Standard Deviation 1.992 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 2 | -0.57 percentage of cells | Standard Deviation 0.357 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 40 | -5.92 percentage of cells | Standard Deviation 2.266 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 3 Day 15 | -6.72 percentage of cells | Standard Deviation 2.08 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15 | -6.09 percentage of cells | Standard Deviation 2.081 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 20 | -0.52 percentage of cells | Standard Deviation 0.421 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2 | -0.54 percentage of cells | Standard Deviation 0.357 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days | -0.65 percentage of cells | Standard Deviation 0.469 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 2 | -6.73 percentage of cells | Standard Deviation 2.09 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 36 | -0.59 percentage of cells | Standard Deviation 0.4 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 4 | -6.09 percentage of cells | Standard Deviation 2.092 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Baseline | 0.60 percentage of cells | Standard Deviation 0.367 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days | -6.74 percentage of cells | Standard Deviation 2.156 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 48 | -7.39 percentage of cells | Standard Deviation 2.174 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 20 | -6.65 percentage of cells | Standard Deviation 2.2 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 24 | -0.59 percentage of cells | Standard Deviation 0.444 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 8 | -6.08 percentage of cells | Standard Deviation 2.093 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 16 | -6.89 percentage of cells | Standard Deviation 2.178 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 44 | -6.59 percentage of cells | Standard Deviation 2.296 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 28 | -0.60 percentage of cells | Standard Deviation 0.368 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 1 Day 2 | -6.70 percentage of cells | Standard Deviation 2.123 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 48 | -0.71 percentage of cells | Standard Deviation 0.414 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 12 | -6.47 percentage of cells | Standard Deviation 1.907 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 40 | -6.56 percentage of cells | Standard Deviation 2.299 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 25 | -6.74 percentage of cells | Standard Deviation 2.148 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 36 | -6.64 percentage of cells | Standard Deviation 2.255 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 36 | -5.97 percentage of cells | Standard Deviation 2.233 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 12 | -7.14 percentage of cells | Standard Deviation 1.82 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Naïve (CD19+CD27-): Change from Baseline to Week 16 | -6.27 percentage of cells | Standard Deviation 2.184 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | Memory (CD19+CD27+): Change from Baseline to Week 44 | -0.62 percentage of cells | Standard Deviation 0.444 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Change from Baseline to Week 28 | -6.64 percentage of cells | Standard Deviation 2.258 |
| Cohort 6 | Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells | B Cells (CD19+): Baseline | 6.78 percentage of cells | Standard Deviation 2.097 |
Secondary
Change From Baseline in Sustained B Cell
Sustained B cell reduction is defined as B-cell reductions achieved on pre-dose at Week 24 and Week 48.
Time frame: Baseline to pre-dose at Week 24 and Week 48
Population: ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 24 | -7.21 percentage of cells | Standard Deviation 4.068 |
| Cohort 1 | Change From Baseline in Sustained B Cell | Baseline | 7.40 percentage of cells | Standard Deviation 4.108 |
| Cohort 1 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 48 | -7.25 percentage of cells | Standard Deviation 4.086 |
| Cohort 2 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 24 | -7.53 percentage of cells | Standard Deviation 3.399 |
| Cohort 2 | Change From Baseline in Sustained B Cell | Baseline | 7.89 percentage of cells | Standard Deviation 3.899 |
| Cohort 2 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 48 | -6.71 percentage of cells | Standard Deviation 2.854 |
| Cohort 3 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 24 | -7.76 percentage of cells | Standard Deviation 4.478 |
| Cohort 3 | Change From Baseline in Sustained B Cell | Baseline | 7.24 percentage of cells | Standard Deviation 4.586 |
| Cohort 3 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 48 | -6.87 percentage of cells | Standard Deviation 4.542 |
| Cohort 4 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 24 | -7.39 percentage of cells | Standard Deviation 2.94 |
| Cohort 4 | Change From Baseline in Sustained B Cell | Baseline | 8.11 percentage of cells | Standard Deviation 2.696 |
| Cohort 4 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 48 | -7.73 percentage of cells | Standard Deviation 2.621 |
| Cohort 5 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 24 | -5.65 percentage of cells | Standard Deviation 2.377 |
| Cohort 5 | Change From Baseline in Sustained B Cell | Baseline | 5.71 percentage of cells | Standard Deviation 2.368 |
| Cohort 5 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 48 | -5.67 percentage of cells | Standard Deviation 2.342 |
| Cohort 6 | Change From Baseline in Sustained B Cell | Baseline | 6.78 percentage of cells | Standard Deviation 2.097 |
| Cohort 6 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 48 | -7.39 percentage of cells | Standard Deviation 2.174 |
| Cohort 6 | Change From Baseline in Sustained B Cell | Change at Pre-dose at Week 24 | -5.62 percentage of cells | Standard Deviation 1.992 |
Secondary
Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
The Gd-enhancing T1 lesions were evaluated using magnetic resonance imaging (MRI) technique.
Time frame: Weeks 24 and 48
Population: ITT population included all participants who received at least one dose of ublituximab. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 24 | 0.0 lesions | Standard Deviation 0 |
| Cohort 1 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 48 | 0.0 lesions | Standard Deviation 0 |
| Cohort 2 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 24 | 0.0 lesions | Standard Deviation 0 |
| Cohort 2 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 48 | 0.0 lesions | Standard Deviation 0 |
| Cohort 3 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 24 | 0.0 lesions | Standard Deviation 0 |
| Cohort 3 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 48 | 0.0 lesions | Standard Deviation 0 |
| Cohort 4 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 24 | 0.0 lesions | Standard Deviation 0 |
| Cohort 4 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 48 | 0.0 lesions | Standard Deviation 0 |
| Cohort 5 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 24 | 0.0 lesions | Standard Deviation 0 |
| Cohort 5 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 48 | 0.0 lesions | Standard Deviation 0 |
| Cohort 6 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 24 | 0.0 lesions | Standard Deviation 0 |
| Cohort 6 | Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 | Week 48 | 0.0 lesions | Standard Deviation 0 |
Secondary
Number of New or Enlarging T2 Lesions at Weeks 24 and 48
The new or enlarging T2 lesions were evaluated using MRI technique.
Time frame: Weeks 24 and 48
Population: ITT population included all participants who received at least one dose of ublituximab. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 24 | 0.38 lesions | Standard Deviation 0.52 |
| Cohort 1 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 48 | 0.25 lesions | Standard Deviation 0.71 |
| Cohort 2 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 24 | 0.29 lesions | Standard Deviation 0.49 |
| Cohort 2 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 48 | 0.00 lesions | Standard Deviation 0 |
| Cohort 3 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 24 | 0.00 lesions | Standard Deviation 0 |
| Cohort 3 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 48 | 0.00 lesions | Standard Deviation 0 |
| Cohort 4 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 24 | 0.25 lesions | Standard Deviation 0.71 |
| Cohort 4 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 48 | 0.00 lesions | Standard Deviation 0 |
| Cohort 5 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 24 | 0.00 lesions | Standard Deviation 0 |
| Cohort 5 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 48 | 0.00 lesions | Standard Deviation 0 |
| Cohort 6 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 24 | 0.14 lesions | Standard Deviation 0.38 |
| Cohort 6 | Number of New or Enlarging T2 Lesions at Weeks 24 and 48 | Week 48 | 0.00 lesions | Standard Deviation 0 |
Secondary
Percentage of Relapse Free Participants
Participant was considered as free of clinical relapse if participant had no confirmed clinical relapse before treatment discontinuation/until end of Week 48. Relapses are defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS), and immediately preceded by a stable or improving neurological state of at least 30 days.
Time frame: Week 48
Population: ITT population included all participants who received at least one dose of ublituximab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Relapse Free Participants | 75.0 percentage of participants |
| Cohort 2 | Percentage of Relapse Free Participants | 100.0 percentage of participants |
| Cohort 3 | Percentage of Relapse Free Participants | 87.5 percentage of participants |
| Cohort 4 | Percentage of Relapse Free Participants | 87.5 percentage of participants |
| Cohort 5 | Percentage of Relapse Free Participants | 100.0 percentage of participants |
| Cohort 6 | Percentage of Relapse Free Participants | 100.0 percentage of participants |
Secondary
Pharmacokinetic Parameter: Plasma Concentration of Ublituximab
Plasma concentration is defined as the measured concentration of ublituximab.
Time frame: Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25
Population: Data for this outcome measure is not reported here because as per pre-specified plan, the analysis includes pooled data from participants enrolled in multiple studies including those who were not enrolled in this study.
Secondary
Relapse Rate Reduction (RRR)
RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.
Time frame: Baseline to Week 48
Population: ITT population included all participants who received at least one dose of ublituximab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Relapse Rate Reduction (RRR) | 75.55 percentage reduction |
| Cohort 2 | Relapse Rate Reduction (RRR) | 100.00 percentage reduction |
| Cohort 3 | Relapse Rate Reduction (RRR) | 87.80 percentage reduction |
| Cohort 4 | Relapse Rate Reduction (RRR) | 89.04 percentage reduction |
| Cohort 5 | Relapse Rate Reduction (RRR) | 100.00 percentage reduction |
| Cohort 6 | Relapse Rate Reduction (RRR) | 100.00 percentage reduction |