A Phase 1/2 interventional study of P-BCMA-101 CAR-T cells and Rimiducid in Multiple Myeloma, sponsored by Poseida Therapeutics, Inc.. Terminated at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Poseida Therapeutics, Inc. (part of Hoffmann-La Roche) · Phase 1/2, Interventional, and Treatment
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.
Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient across 1-3 infusions, with or without combination therapy. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 105 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Poseida Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
First submitted before Poseida Therapeutics, Inc. became part of Hoffmann-La Roche.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
CAR-T cells administered via intravenous infusion as a total dose
Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid
P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a "safety switch" gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.
Rimiducid (safety switch activator) may be administered as indicated.
Phase 1: Assess the Safety of P-BCMA-101
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through Day 28
Phase 1: Maximum Tolerated Dose of P-BCMA-101
Rate of dose limiting toxicities (DLT)
Time frame: Baseline through Day 28
Phase 2: Assess the Safety of P-BCMA-101
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through 24 months
Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)
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).
Time frame: Baseline through 24 months
Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)
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.
Time frame: Baseline through 24 months
Phase 1:Assess the Safety of P-BCMA-101
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through Month 24
Phase 1:Assess the Feasibility P-BCMA-101
Ability to generate protocol-prescribed doses of P-BCMA-101.
Time frame: Baseline through Month 24
Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)
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).
Time frame: Baseline through Month 24
Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)
According 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.
Time frame: Baseline through Month 24
Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)
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.
Time frame: Baseline through Month 24
Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)
According 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.
Time frame: Baseline through Month 24
Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)
According 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.
Time frame: Baseline through Month 24
Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies
Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Time frame: Baseline through Month 24
Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)
Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Time frame: Baseline through Month 24
Phase 2: Evaluate Efficacy Endpoints (IL-6)
Rate of IL-6 antagonist
Time frame: Baseline through Month 24
Phase 2: Evaluate Efficacy Endpoints (C)
Corticosteroid Use
Time frame: Baseline through Month 24
Phase 2: Evaluate Efficacy Endpoints (R)
Rimiducid Use
Time frame: Baseline through Month 24
Phase 2: Evaluate Efficacy Endpoints (OS)
According 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.
Time frame: Baseline through Month 24
Phase 2: Evaluate Efficacy Endpoints (PFS)
According 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.
Time frame: Baseline through Month 24
Phase 2: Evaluate Efficacy Endpoints (TTR)
According 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.
Time frame: Baseline through Month 24
Phase 2: Evaluate Efficacy Endpoints (MRD)
Minimum residual disease negative rate
Time frame: Baseline through Month 24
| Milestone | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells |
|---|---|---|---|---|---|---|---|
| Started | 69 | 3 | 1 | 8 | 5 | 16 | 3 |
| Completed | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 66 | 3 | 1 | 8 | 5 | 16 | 3 |
| Withdrew: Withdrawal by subject | 4 | 0 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Significant progression of malignancy requiring alternative, medical, radiation or surgical interven | 52 | 3 | 1 | 6 | 5 | 10 | 3 |
| Withdrew: 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 |
| Withdrew: Death | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other reason not listed above | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Incidence and severity of treatment-emergent adverse events
| Participants | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) |
|---|---|---|---|---|---|---|
| TEAE Related to P-BCMA-101 | 56 | 3 | 0 | 7 | 2 | 13 |
| TEAE Not Related to P-BCMA-101 | 11 | 0 | 1 | 1 | 3 | 3 |
Rate of dose limiting toxicities (DLT)
| Participants | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells |
|---|---|---|---|---|---|---|---|
| Phase 1: Maximum Tolerated Dose of P-BCMA-101 | 0 | 0 | 0 | 0 | 0 | 0 | NA |
Incidence and severity of treatment-emergent adverse events
| Participants | Phase 2: P-BCMA-101 CAR-T Cells |
|---|---|
| TEAE Related to P-BCMA-101 | 2 |
| TEAE Not Related to P-BCMA-101 | 1 |
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Incidence and severity of treatment-emergent adverse events
Results for this outcome have not been posted.
Ability to generate protocol-prescribed doses of P-BCMA-101.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
According 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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
According 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.
Results for this outcome have not been posted.
According 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.
Results for this outcome have not been posted.
Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Results for this outcome have not been posted.
Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Results for this outcome have not been posted.
Rate of IL-6 antagonist
Results for this outcome have not been posted.
Corticosteroid Use
Results for this outcome have not been posted.
Rimiducid Use
Results for this outcome have not been posted.
According 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.
Results for this outcome have not been posted.
According 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.
Results for this outcome have not been posted.
According 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.
Results for this outcome have not been posted.
Minimum residual disease negative rate
Results for this outcome have not been posted.
Collected over Baseline through Month 24. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1: P-BCMA-101 CAR-T Cells | 23/69 (33.3%) | 39/69 (56.5%) | 63/69 (91.3%) |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | 3/8 (37.5%) | 7/8 (87.5%) | 7/8 (87.5%) |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | 1/5 (20%) | 2/5 (40%) | 5/5 (100%) |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | 0/16 (0%) | 6/16 (37.5%) | 16/16 (100%) |
| Phase 2: P-BCMA-101 CAR-T Cells | 1/3 (33.3%) | 2/3 (66.7%) | 3/3 (100%) |
| Retreatment | 2/5 (40%) | 2/5 (40%) | 4/5 (80%) |
| Event | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells | Retreatment |
|---|---|---|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 16/69 | 1/3 | 1/1 | 2/8 | 0/5 | 1/16 | 0/3 | 1/5 |
| Cytokine release syndromeImmune system disorders | 6/69 | 0/3 | 0/1 | 3/8 | 0/5 | 2/16 | 1/3 | 0/5 |
| Progressive multifocal leukoencephalopathyInfections and infestations | 0/69 | 0/3 | 0/1 | 0/8 | 0/5 | 0/16 | 1/3 | 0/5 |
| Urinary tract infectionInfections and infestations | 0/69 | 0/3 | 0/1 | 0/8 | 0/5 | 0/16 | 1/3 | 0/5 |
| PneumoniaInfections and infestations | 6/69 | 0/3 | 0/1 | 1/8 | 0/5 | 1/16 | 0/3 | 1/5 |
| PancytopeniaBlood and lymphatic system disorders | 0/69 | 0/3 | 0/1 | 0/8 | 1/5 | 0/16 | 0/3 | 0/5 |
| Staphylococcal bacteraemiaInfections and infestations | 0/69 | 0/3 | 0/1 | 0/8 | 1/5 | 0/16 | 0/3 | 0/5 |
| HypervolaemiaMetabolism and nutrition disorders | 0/69 | 0/3 | 0/1 | 0/8 | 0/5 | 0/16 | 0/3 | 1/5 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/69 | 0/3 | 0/1 | 0/8 | 0/5 | 0/16 | 0/3 | 1/5 |
| Transfusion reactionInjury, poisoning and procedural complications | 0/69 | 0/3 | 0/1 | 0/8 | 0/5 | 0/16 | 0/3 | 1/5 |
| Event | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells | Retreatment |
|---|---|---|---|---|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 48/69 | 3/3 | 0/1 | 3/8 | 5/5 | 13/16 | 2/3 | 3/5 |
| ThrombocytopeniaBlood and lymphatic system disorders | 32/69 | 3/3 | 0/1 | 5/8 | 2/5 | 6/16 | 2/3 | 3/5 |
| AnaemiaBlood and lymphatic system disorders | 33/69 | 1/3 | 1/1 | 2/8 | 3/5 | 5/16 | 2/3 | 2/5 |
| LeukopeniaBlood and lymphatic system disorders | 20/69 | 3/3 | 1/1 | 3/8 | 1/5 | 6/16 | 2/3 | 3/5 |
| Decreased appetiteMetabolism and nutrition disorders | 12/69 | 0/3 | 1/1 | 2/8 | 0/5 | 2/16 | 1/3 | 1/5 |
| DiarrhoeaGastrointestinal disorders | 19/69 | 1/3 | 0/1 | 2/8 | 0/5 | 6/16 | 2/3 | 0/5 |
| FatigueGeneral disorders | 22/69 | 2/3 | 0/1 | 5/8 | 1/5 | 5/16 | 1/3 | 1/5 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 5/69 | 2/3 | 0/1 | 1/8 | 0/5 | 1/16 | 0/3 | 0/5 |
| HeadacheNervous system disorders | 13/69 | 2/3 | 0/1 | 0/8 | 1/5 | 2/16 | 0/3 | 0/5 |
| PyrexiaGeneral disorders | 19/69 | 0/3 | 0/1 | 3/8 | 0/5 | 3/16 | 1/3 | 0/5 |
| Age, Categorical(Participants) | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 39 | 2 | 1 | 5 | 3 | 8 | 2 | 60 |
| >=65 years | 30 | 1 | 0 | 3 | 2 | 8 | 1 | 45 |
| Sex: Female, Male(Participants) | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 23 | 0 | 1 | 4 | 2 | 7 | 2 | 39 |
| Male | 46 | 3 | 0 | 4 | 3 | 9 | 1 | 66 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 0 | 0 | 0 | 1 | 1 | 0 | 7 |
| Not Hispanic or Latino | 60 | 3 | 1 | 8 | 3 | 14 | 3 | 92 |
| Unknown or Not Reported | 4 | 0 | 0 | 0 | 1 | 1 | 0 | 6 |
| Race (NIH/OMB)(Participants) | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 13 | 1 | 0 | 2 | 0 | 3 | 1 | 20 |
| White | 48 | 1 | 1 | 6 | 3 | 10 | 2 | 71 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 0 | 0 | 0 | 2 | 2 | 0 | 11 |
| Region of Enrollment(participants) | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 69 | 3 | 1 | 8 | 5 | 16 | 3 | 105 |
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