Fate Therapeutics, Inc. (NASDAQ: FATE) reported updated clinical data from its Phase 1 study of the off‑the‑shelf CAR‑T product FT819 in moderate‑to‑severe systemic lupus erythematosus (SLE). The data, presented at the ACR Convergence 2025 conference in Chicago, are based on the first 10 patients enrolled and have a data cut‑off of September 25, 2025.
All 10 patients received either a fludarabine‑free conditioning regimen of cyclophosphamide or bendamustine, or no conditioning while on standard‑of‑care maintenance. No dose‑limiting toxicities were observed, and the safety profile supports the possibility of same‑day discharge for patients.
Of the 10 patients, 5 had reached a 3‑month post‑treatment time point and showed significant reductions in the SLE Disease Activity Index (SLEDAI‑2K) and Physician’s Global Assessment (PGA) scores. Two patients with lupus nephritis achieved complete renal response at 6 months, and the first patient remains in drug‑free remission at 15 months of follow‑up. The data also demonstrate rapid CD19+ B‑cell depletion and immune remodeling toward a naïve, less‑pathogenic B‑cell repertoire.
These updated results build on earlier data presented at ASH 2024 and EULAR 2025, and represent the most recent evidence of efficacy and safety for FT819 in SLE. The Phase 1 study (NCT06308978) is evaluating two dose levels—360 million cells and 900 million cells—and is planned to expand to other B‑cell‑mediated autoimmune diseases such as anti‑neutrophil cytoplasmic antibody‑associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis later in 2025. Fate Therapeutics received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for FT819 in April 2025 and is in ongoing discussions with the agency about novel registrational strategies under that designation.
The favorable safety profile and evidence of rapid B‑cell depletion support the potential for outpatient administration of FT819, which could broaden access to this novel therapy for patients with moderate‑to‑severe SLE.
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