Fate Therapeutics has released updated clinical data for its lead off‑the‑shelf CAR T‑cell therapy, FT819, in Phase 1 trials for patients with moderate‑to‑severe systemic lupus erythematosus (SLE). The new results show meaningful and durable reductions in disease activity, including complete renal responses in lupus nephritis patients and sustained improvements with favourable safety profiles, even with less‑intensive or no conditioning chemotherapy. The company is now expanding the trial across additional U.S. and international sites and continues discussions with the U.S. FDA under its Regenerative Medicine Advanced Therapy (RMAT) designation as it plans a pivotal registrational study in 2026.
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