Reported Sunday, Fate Therapeutics Presents FT819 Phase 1 Data Demonstrating Immune Remodeling And Durable Responses In 10 Patients With Systemic Lupus Erythematosus
Benzinga Newsdesk 1 year ago
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As of a September 25, 2025 data cut-off-date, 10 patients with treatment-refractory, moderate-to-severe Systemic Lupus Erythematosus (SLE) were treated with a single dose of FT819 with less-intensive or no conditioning
- As of a September 25, 2025 data cut-off-date, 10 patients with treatment-refractory, moderate-to-severe Systemic Lupus Erythematosus (SLE) were treated with a single dose of FT819 with less-intensive or no conditioning chemotherapy
- Favorable safety profile with no dose-limiting toxicities supports plan to enable same-day discharge post FT819 treatment broadening patient accessibility
- All patients surpassing a 3-month post-treatment time point (n=5) showed significant reductions in the SLE Disease Activity Index (SLEDAI-2K) score and Physician's Global Assessment (PGA)
- SLE patients with lupus nephritis (LN) surpassing a 3-month post-treatment time point (n=2) achieved complete renal response (CRR) at 6 months; first patient continues in drug-free Definition of Remission in SLE (DORIS) at 15 months follow-up
- Cumulative clinical dataset provides clear evidence for rapid CD19+ B cell depletion and immune remodeling toward a naïve and less pathogenic B-cell repertoire