Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
P-MUC1C-ALLO1 CAR-T cells · 1 trial · 9 indications
Number of subjects with a dose limiting toxicity (DLT)
Frequency and severity of adverse events
According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR)
| Arm | Type | Description |
|---|---|---|
| P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A) | EXPERIMENTAL | * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated. |
| P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B) | EXPERIMENTAL | * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated. |
| P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C) | EXPERIMENTAL | * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated. |
| P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D) | EXPERIMENTAL | * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated. |
| P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A1) | EXPERIMENTAL | * Single ascending A1 dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated. |
| P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm E) | EXPERIMENTAL | * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated. |
| P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm F) | EXPERIMENTAL | * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated. |
| P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm M) | EXPERIMENTAL | * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated. |
| Name | Type | Description |
|---|---|---|
| P-MUC1C-ALLO1 CAR-T cells | BIOLOGICAL | P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C. |
| Rimiducid | DRUG | Rimiducid (safety switch activator) may be administered as indicated. |
Inclusion Criteria: * Males or females, Subjects ≥18 years with life expectancy \>3 months * Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer * Must have progressed during or after last therapy, developed intolerance/toxicity to current treat...
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