Posted by Michael Wonder on 16 Apr 2025
Fate Therapeutics receives regenerative medicine advanced therapy designation from FDA for FT819 to treat moderate to severe systemic lupus erythematosus
14 April 2025 - Fate Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to FT819, an investigational, off the shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the treatment of active moderate to severe systemic lupus erythematosus, including lupus nephritis.
The Company’s RMAT application included initial clinical safety and activity data from patients treated with FT819 in its ongoing multi-centre Phase 1 clinical trial.
