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Phase I portion of the study was completed. The phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
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| Name | Class |
|---|---|
| California Institute for Regenerative Medicine (CIRM) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: P-BCMA-101 CAR-T cells | Experimental | Single ascending 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) | Experimental | 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) | Experimental | 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 (Cohort C) | Experimental | 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 with Comb.Therapy (Cohort R) | Experimental | Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-BCMA-101 CAR-T cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Assess the Safety of P-BCMA-101 | Incidence and severity of treatment-emergent adverse events | Baseline through Day 28 |
| Phase 1: Maximum Tolerated Dose of P-BCMA-101 | Rate of dose limiting toxicities (DLT) | Baseline through Day 28 |
| Phase 2: Assess the Safety of P-BCMA-101 | Incidence and severity of treatment-emergent adverse events | 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). | 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. | Baseline through 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1:Assess the Safety of P-BCMA-101 | Incidence and severity of treatment-emergent adverse events | Baseline through Month 24 |
| Phase 1:Assess the Feasibility P-BCMA-101 | Ability to generate protocol-prescribed doses of P-BCMA-101. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Belani, M.D. | Sponsor Executive Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| University of California Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31215818 | Derived | Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2019 |
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Phase 1: open label, 3 + 3 design of dose-escalating cohorts Phase 2: open label, administered as a total dose
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|
| Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP) | Experimental | 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) | Experimental | 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 | Experimental | CAR-T cells administered via intravenous infusion as a total dose |
|
|
| Rimiducid | Drug | Rimiducid (safety switch activator) may be administered as indicated. |
|
| 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). | 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. | 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. | 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. | 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. | 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) | 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) | Baseline through Month 24 |
| Phase 2: Evaluate Efficacy Endpoints (IL-6) | Rate of IL-6 antagonist | Baseline through Month 24 |
| Phase 2: Evaluate Efficacy Endpoints (C) | Corticosteroid Use | Baseline through Month 24 |
| Phase 2: Evaluate Efficacy Endpoints (R) | Rimiducid Use | 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. | 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. | 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. | Baseline through Month 24 |
| Phase 2: Evaluate Efficacy Endpoints (MRD) | Minimum residual disease negative rate | Baseline through Month 24 |
| Davis |
| California |
| 95618 |
| United States |
| University of California San Diego | San Diego | California | 92093 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21231 | United States |
| Wayne State - Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute at Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | Phase 2: P-BCMA-101 CAR-T Cells | CAR-T cells administered via intravenous infusion as a total dose |
| COMPLETED | Completed Study is defined as a subject completing Post-Treatment Follow-up Visits to Month 24. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Phase 2: P-BCMA-101 CAR-T Cells | CAR-T cells administered via intravenous infusion as a total dose |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Assess the Safety of P-BCMA-101 | Incidence and severity of treatment-emergent adverse events | Posted | Count of Participants | Participants | Baseline through Day 28 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | Rate of dose limiting toxicities (DLT) | Posted | Count of Participants | Participants | Baseline through Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 2: Assess the Safety of P-BCMA-101 | Incidence and severity of treatment-emergent adverse events | Posted | Count of Participants | Participants | Baseline through 24 months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | 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). | 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. | Posted | Baseline through 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Baseline through 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1:Assess the Safety of P-BCMA-101 | Incidence and severity of treatment-emergent adverse events | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1:Assess the Feasibility P-BCMA-101 | Ability to generate protocol-prescribed doses of P-BCMA-101. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS) | Incidence and severity of CRS events graded using Lee criteria (Lee, 2014) | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Evaluate Efficacy Endpoints (IL-6) | Rate of IL-6 antagonist | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Evaluate Efficacy Endpoints (C) | Corticosteroid Use | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Evaluate Efficacy Endpoints (R) | Rimiducid Use | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline through Month 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Evaluate Efficacy Endpoints (MRD) | Minimum residual disease negative rate | Not Posted | Baseline through Month 24 | Participants |
Baseline through Month 24
Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 23 | 69 | 39 | 69 | 63 | 69 |
| EG001 | 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. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 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. | 0 | 1 | 1 | 1 | 1 | 1 |
| EG003 | 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. | 3 | 8 | 7 | 8 | 7 | 8 |
| EG004 | 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. | 1 | 5 | 2 | 5 | 5 | 5 |
| EG005 | 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. | 0 | 16 | 6 | 16 | 16 | 16 |
| EG006 | Phase 2: P-BCMA-101 CAR-T Cells | CAR-T cells administered via intravenous infusion as a total dose | 1 | 3 | 2 | 3 | 3 | 3 |
| EG007 | Retreatment | 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. | 2 | 5 | 2 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia adenoviral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Belani, MD, Vice President Clinical Development | Poseida Therapeutics | 858-779-3100 | rbelani@poseida.com |
| Apr 19, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| TEAE Not Related to P-BCMA-101 |
|
| OG004 |
| 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. |
| OG005 | 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. |
| OG006 | Phase 2: P-BCMA-101 CAR-T Cells | CAR-T cells administered via intravenous infusion as a total dose |
|
|
|