The U.S. FDA has granted Fate Therapeutics regenerative medicine advanced therapy (RMAT) designation for its investigational, off-the-shelf, induced pluripotent stem cell (iPSC)-derived CAR T-cell therapy, currently in phase 1 development for the treatment of active moderate to severe systemic lupus erythematosus.
FT819 is designed to provide CAR-T cell therapy on-demand in a cost-effective manner and alleviate patient burden associated with intense conditioning chemotherapy and extended hospitalization. Fate hopes this will enable treatment in the community setting and access for patients in underserved areas.
The RMAT application included initial clinical safety and activity data from patients treated with FT819 in an ongoing multi-center phase 1 clinical trial evaluating the safety and efficacy of a fludarabine-free conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, followed by a single dose of FT819.
The clinical development of FT819 is supported by a $7.9 million grant from the California Institute of Regenerative Medicine (CIRM) awarded to Fate last year.
Fate plans to report additional clinical data from the phase 1 study of FT819 at scientific meetings later in 2025.
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