Trial Outcomes & Findings for P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM) (NCT NCT03288493)
NCT ID: NCT03288493
Last Updated: 2024-03-28
Results Overview
Incidence and severity of treatment-emergent adverse events
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline through Day 28
Results posted on
2024-03-28
Participant Flow
Participant milestones
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
CAR-T cells administered via intravenous infusion as a total dose
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
3
|
1
|
8
|
5
|
16
|
3
|
|
Overall Study
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
66
|
3
|
1
|
8
|
5
|
16
|
3
|
Reasons for withdrawal
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
CAR-T cells administered via intravenous infusion as a total dose
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Significant progression of malignancy requiring alternative, medical, radiation or surgical interven
|
52
|
3
|
1
|
6
|
5
|
10
|
3
|
|
Overall Study
Termination of the study by the PI, the sponsor, the study funder, the IRB/IEC or the FDA
|
6
|
0
|
0
|
2
|
0
|
4
|
0
|
|
Overall Study
Death
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
other reason not listed above
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Baseline characteristics by cohort
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
n=69 Participants
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
n=3 Participants
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
n=1 Participants
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
n=8 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
n=5 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
n=16 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
n=3 Participants
CAR-T cells administered via intravenous infusion as a total dose
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
60 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
45 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
39 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
66 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
92 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
71 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
5 participants
n=21 Participants
|
16 participants
n=10 Participants
|
3 participants
n=115 Participants
|
105 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 28Incidence and severity of treatment-emergent adverse events
Outcome measures
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
n=67 Participants
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
n=3 Participants
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
n=1 Participants
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
n=8 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
n=5 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
n=16 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
CAR-T cells administered via intravenous infusion as a total dose
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Assess the Safety of P-BCMA-101
TEAE Related to P-BCMA-101
|
56 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
13 Participants
|
—
|
|
Phase 1: Assess the Safety of P-BCMA-101
TEAE Not Related to P-BCMA-101
|
11 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 28Rate of dose limiting toxicities (DLT)
Outcome measures
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
n=69 Participants
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
n=3 Participants
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
n=1 Participants
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
n=8 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
n=5 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
n=16 Participants
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
n=3 Participants
CAR-T cells administered via intravenous infusion as a total dose
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose of P-BCMA-101
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
NA Participants
DLT not applicable for Phase 2 participants
|
PRIMARY outcome
Timeframe: Baseline through 24 monthsIncidence and severity of treatment-emergent adverse events
Outcome measures
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
n=3 Participants
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
CAR-T cells administered via intravenous infusion as a total dose
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Assess the Safety of P-BCMA-101
TEAE Related to P-BCMA-101
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Assess the Safety of P-BCMA-101
TEAE Not Related to P-BCMA-101
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through 24 monthsPopulation: Independent Review Committee (IRC) was not formed to assess ORR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline through 24 monthsPopulation: Independent Review Committee (IRC) was not formed to assess DOR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Incidence and severity of treatment-emergent adverse events
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Ability to generate protocol-prescribed doses of P-BCMA-101.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Rate of IL-6 antagonist
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Corticosteroid Use
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Rimiducid Use
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Month 24Minimum residual disease negative rate
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: P-BCMA-101 CAR-T Cells
Serious events: 39 serious events
Other events: 63 other events
Deaths: 23 deaths
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 3 deaths
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase 2: P-BCMA-101 CAR-T Cells
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Retreatment
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
n=69 participants at risk
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
n=3 participants at risk
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
n=1 participants at risk
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
n=8 participants at risk
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
n=5 participants at risk
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
n=16 participants at risk
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
n=3 participants at risk
CAR-T cells administered via intravenous infusion as a total dose
|
Retreatment
n=5 participants at risk
If a subject's disease progressed and sufficient P-BCMA-101 cells were available from initial manufacturing, a subject may have received an additional P-BCMA-101 infusion at up to the highest dose level that had completed DLT assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.2%
16/69 • Number of events 17 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
1/1 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Pneumonia
|
8.7%
6/69 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Sepsis
|
2.9%
2/69 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Sinusitis
|
2.9%
2/69 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Bacterial sepsis
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Clostridium difficile infection
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Escherichia bacteraemia
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Influenza
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Skin infection
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Klebsiella infection
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Pilonidal cyst
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Pneumonia adenoviral
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Wound infection
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Immune system disorders
Cytokine release syndrome
|
8.7%
6/69 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
3/8 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Pyrexia
|
4.3%
3/69 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Asthenia
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Disease progression
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Nervous system disorders
Neurotoxicity
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Nervous system disorders
Syncope
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Gout
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/69 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Nervous system disorders
Aphasia
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Vascular disorders
Hypotension
|
1.4%
1/69 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/69 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
Other adverse events
| Measure |
Phase 1: P-BCMA-101 CAR-T Cells
n=69 participants at risk
Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
n=3 participants at risk
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
n=1 participants at risk
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
n=8 participants at risk
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
n=5 participants at risk
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
|
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
n=16 participants at risk
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
|
Phase 2: P-BCMA-101 CAR-T Cells
n=3 participants at risk
CAR-T cells administered via intravenous infusion as a total dose
|
Retreatment
n=5 participants at risk
If a subject's disease progressed and sufficient P-BCMA-101 cells were available from initial manufacturing, a subject may have received an additional P-BCMA-101 infusion at up to the highest dose level that had completed DLT assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
69.6%
48/69 • Number of events 189 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
3/3 • Number of events 8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
3/8 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
5/5 • Number of events 12 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
81.2%
13/16 • Number of events 32 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
60.0%
3/5 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
46.4%
32/69 • Number of events 132 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
3/3 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
62.5%
5/8 • Number of events 8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
40.0%
2/5 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
6/16 • Number of events 8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
60.0%
3/5 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Blood and lymphatic system disorders
Anaemia
|
47.8%
33/69 • Number of events 92 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
1/1 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
60.0%
3/5 • Number of events 5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
31.2%
5/16 • Number of events 10 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
40.0%
2/5 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Blood and lymphatic system disorders
Leukopenia
|
29.0%
20/69 • Number of events 49 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
3/3 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
1/1 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
3/8 • Number of events 5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
6/16 • Number of events 10 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
60.0%
3/5 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Nausea
|
36.2%
25/69 • Number of events 33 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
4/16 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.5%
19/69 • Number of events 23 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
6/16 • Number of events 7 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Constipation
|
20.3%
14/69 • Number of events 18 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
12/69 • Number of events 12 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
3/69 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Fatigue
|
31.9%
22/69 • Number of events 27 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
62.5%
5/8 • Number of events 7 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
31.2%
5/16 • Number of events 5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Pyrexia
|
27.5%
19/69 • Number of events 26 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
3/8 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
18.8%
3/16 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Oedema peripheral
|
11.6%
8/69 • Number of events 8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Pain
|
5.8%
4/69 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
General disorders
Chills
|
2.9%
2/69 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Immune system disorders
Cytokine release syndrome
|
26.1%
18/69 • Number of events 22 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.5%
10/69 • Number of events 10 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Investigations
Lymphocyte count decreased
|
10.1%
7/69 • Number of events 13 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Investigations
Blood creatinine increased
|
4.3%
3/69 • Number of events 5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
26.1%
18/69 • Number of events 30 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
18.8%
3/16 • Number of events 5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
21.7%
15/69 • Number of events 29 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.4%
12/69 • Number of events 13 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
100.0%
1/1 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.9%
11/69 • Number of events 13 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.1%
7/69 • Number of events 8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.1%
7/69 • Number of events 10 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
25.0%
2/8 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.7%
6/69 • Number of events 10 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.8%
4/69 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.8%
13/69 • Number of events 15 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.9%
11/69 • Number of events 12 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.7%
6/69 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.2%
5/69 • Number of events 5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
6/69 • Number of events 7 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Nervous system disorders
Headache
|
18.8%
13/69 • Number of events 15 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
66.7%
2/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Nervous system disorders
Dizziness
|
5.8%
4/69 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
3/69 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/16 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.5%
10/69 • Number of events 11 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
18.8%
3/16 • Number of events 3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.2%
5/69 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
37.5%
3/8 • Number of events 4 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
33.3%
1/3 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.8%
4/69 • Number of events 6 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
1/8 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
6.2%
1/16 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
|
Vascular disorders
Hypotension
|
11.6%
8/69 • Number of events 9 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/8 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
20.0%
1/5 • Number of events 1 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
12.5%
2/16 • Number of events 2 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/3 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
0.00%
0/5 • Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
|
Additional Information
Rajesh Belani, MD, Vice President Clinical Development
Poseida Therapeutics
Phone: 858-779-3100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place