Approval Probability
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Adjusted LOA
ML Risk
ALLO-329 · 1 trial · 3 indications
The incidence of dose limiting toxicities (DLTs) and other safety parameters (including but not limited to treatment emergent adverse events \[AEs\], serious adverse events \[SAEs\], and clinical laboratory abnormalities)
| Arm | Type | Description |
|---|---|---|
| ALLO-329, Cyclophosphamide | EXPERIMENTAL | Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide. |
| ALLO-329 | EXPERIMENTAL | Participants receive ALLO-329 without a lymphodepletion regimen. |
| ALLO-329, Cyclophosphamide, Fludarabine | EXPERIMENTAL | Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine. |
| Name | Type | Description |
|---|---|---|
| ALLO-329 | GENETIC | An allogeneic CAR T cell therapy targeting CD19 and CD70 |
| Cyclophosphamide | DRUG | Chemotherapy for lymphodepletion |
| Fludarabine | DRUG | Chemotherapy for lymphodepletion |
Inclusion Criteria: 1. Adults ≥ 18 to \< 75 years of age. 2. Adequate hematological function and liver, cardiac, and pulmonary function. 3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing...
ALLO-329 is an investigational allogeneic CAR T-cell therapy being studied for the treatment of systemic lupus erythematosus (SLE), both with and without nephritis. It is also being evaluated for idiopathic inflammatory myopathy and systemic sclerosis in the same clinical trial.
ALLO-329 targets CD19 and CD70, which are proteins found on certain immune cells. By targeting these molecules, the CAR T-cell therapy is designed to modulate the immune system in autoimmune diseases such as systemic lupus erythematosus.
ALLO-329 is being developed by Allogene Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ALLO. The company is conducting clinical research to evaluate the safety and preliminary efficacy of this therapy.
ALLO-329 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to facilitate development and expedite review.
ALLO-329 is being studied in a Phase 1 clinical trial with the identifier NCT07085104. This trial is currently recruiting participants and is investigating the safety and preliminary efficacy of ALLO-329 in adults with autoimmune diseases, including systemic lupus erythematosus.
ALLO-329 is an allogeneic CAR T-cell therapy, meaning it is manufactured from donor cells rather than a patient's own cells. It targets both CD19 and CD70, which distinguishes it from many CAR T therapies that target only one antigen.