Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
P-BCMA-ALLO1 CAR-T cells · 1 trial · 1 indication
Rate of dose limiting toxicities (DLT)
Frequency and severity of adverse events, including cytokine release syndrome.
Overall response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria
| Arm | Type | Description |
|---|---|---|
| P-BCMA-ALLO1 CAR-T cells (Arm S) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm F) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen F. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm N) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm P1) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm P2) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P2. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm R) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen R. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm RS) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RS. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm C) | EXPERIMENTAL | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen C. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm160) | EXPERIMENTAL | Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm480) | EXPERIMENTAL | Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm P1.5) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.5. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm RP1) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm RP1.5) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.5. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm RP2) | EXPERIMENTAL | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP2. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm CP1) | EXPERIMENTAL | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm CP1.5) | EXPERIMENTAL | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.5. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm CP2) | EXPERIMENTAL | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP2. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm MP1.5) | EXPERIMENTAL | Single weight based IV administration of P-BCMA-ALLO1 and methotrexate following conditioning chemotherapy regimen MP1.5 Rimiducid may be administered as indicated |
| Name | Type | Description |
|---|---|---|
| P-BCMA-ALLO1 CAR-T cells | BIOLOGICAL | Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy |
| Rimiducid | DRUG | Safety switch activator |
| Methotrexate | DRUG | Anti-metabolite |
Inclusion Criteria: 1. Must have signed written, informed consent. 2. Males or females, ≥18 years of age. 3. Must have a confirmed diagnosis of active MM. 4. Must have measurable MM. 5. Must have relapsed / refractory MM, having received treatment with a proteasome inhibitor, immunomodulatory agent...
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P-BCMA-ALLO1 CAR-T cells is an investigational cell therapy being developed for the treatment of multiple myeloma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The therapy is being studied in patients with multiple myeloma, a type of blood cancer.
P-BCMA-ALLO1 CAR-T cells is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational therapy for multiple myeloma.
P-BCMA-ALLO1 CAR-T cells is currently in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively enrolling participants, though recruitment is currently not active.
P-BCMA-ALLO1 CAR-T cells is being studied in a Phase 1 clinical trial registered as NCT04960579. This trial, titled 'P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma,' is active but not recruiting participants. The study is being conducted in the United States and has a planned enrollment of 275 participants.
P-BCMA-ALLO1 CAR-T cells is the full name of the investigational therapy, and it is commonly referred to as P-BCMA-ALLO1 in clinical trial documentation. The therapy is an allogeneic CAR-T cell product targeting BCMA, a protein found on multiple myeloma cells.