FT819

Fate Therapeutics reported positive Phase 1 data for FT819, an off-the-shelf CAR T-cell therapy, in ten treatment-refractory SLE patients. A single dose resulted in rapid B-cell depletion and immune remodeling. The study showed durable clinical responses, including complete renal responses and steroid-free remission. FT819 demonstrated a favorable safety profile with low-grade CRS and no ICANS or GvHD. The data support potential outpatient administration and a pivotal study in 2026. These results suggest FT819’s transformative potential for SLE treatment.