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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