Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04093596 | Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL) | PHASE1 | COMPLETED | 73 | — | — | Sep 23, 2019 | Jan 27, 2025 | May 13, 2026 | 11 | United States |
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
The proportion of subjects in a dose cohort with DLTs of ALLO-647
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
| Arm | Type | Description |
|---|---|---|
| ALLO-647, ALLO-715, Nirogacestat | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALLO-715 | GENETIC | ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA |
| ALLO-647 | BIOLOGICAL | ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen |
| Fludarabine | DRUG | Chemotherapy for lymphodepletion |
| Cyclophosphamide | DRUG | Chemotherapy for lymphodepletion |
| Nirogacestat | DRUG | a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells. |
Inclusion Criteria: * Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (serum, urine, or free light chain \[FLC\]) per International Myeloma Working Group (IMWG) criteria * At least 3 prior lines of MM therapy, including a proteasome inhibitor, immunomodulat...