Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALLO-715 · 1 trial · 1 indication
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...
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ALLO-715 is an investigational gene therapy being developed by Allogene Therapeutics for relapsed or refractory multiple myeloma. It is an allogeneic CAR T cell therapy, meaning the cells are derived from a donor rather than the patient. It has completed a Phase 1 clinical trial and has not been approved by the FDA.
ALLO-715 is being studied for the treatment of adults with relapsed or refractory multiple myeloma, a cancer of plasma cells that has returned or stopped responding to prior therapies. The Phase 1 UNIVERSAL trial enrolled 73 patients with this condition in the United States. It remains investigational and is not approved for commercial use.
ALLO-715 targets BCMA, or B-cell maturation antigen, a protein expressed on the surface of myeloma cells. By binding BCMA, the CAR T cells are designed to recognize and attack malignant plasma cells. BCMA is a validated target in multiple myeloma, and ALLO-715 is engineered as an allogeneic, or donor-derived, CAR T therapy.
ALLO-715 is being developed by Allogene Therapeutics, Inc., a clinical-stage biotechnology company that trades under the ticker ALLO. Allogene focuses on allogeneic CAR T therapies, and ALLO-715 is one of its pipeline assets in oncology. The company sponsored the Phase 1 UNIVERSAL trial of the candidate.
ALLO-715 has completed a Phase 1 clinical trial and remains an investigational therapy that has not received FDA approval. The Phase 1 UNIVERSAL study evaluated safety and efficacy in adults with relapsed or refractory multiple myeloma. ALLO-715 has received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA.
ALLO-715 was evaluated in the Phase 1 UNIVERSAL trial, registered as NCT04093596, titled Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in Adults With Relapsed or Refractory Multiple Myeloma. The trial enrolled 73 patients in the United States and is now completed. It was an uncontrolled, non-randomized study.