Fate Therapeutics shares Phase 1 FT819 data for lupus nephritis

Fate Therapeutics, Inc. (NASDAQ: FATE) presented updated Phase 1 clinical data for its off-the-shelf CAR T-cell candidate FT819 in patients with systemic lupus erythematosus (SLE) with lupus nephritis (LN) at the American Society of Nephrology Kidney Week 2026 in Denver, Colorado.

The oral presentation, delivered Oct. 24 by Dr. Jonathan Graf of the University of California, San Francisco, reported data from the ongoing Phase 1 FT819-102 study as of an Aug. 18, 2026 data cutoff.

Among active LN patients treated with FT819 plus bendamustine conditioning — the regimen selected for the company's ongoing Phase 2 RECLAIM-LN study — all patients evaluable at Month 6 (n=2) achieved either a complete renal response or primary efficacy renal response, with approximately 50% mean reduction in urine protein-to-creatinine ratio from baseline. The renal response was sustained through Month 24 in the single patient who reached that timepoint.

Across all 29 autoimmune patients treated with a single dose of FT819 following less-intensive, fludarabine-free conditioning, no dose-limiting toxicities, ICANS, graft-versus-host disease, or deaths were reported. No cytokine release syndrome above Grade 2 was observed. Grade 3 or higher infections occurred in two patients (6.9%), and Grade 3 or higher cytopenias occurred in six patients (20.7%).

Additional findings showed clinically meaningful reductions in lupus disease activity scores as early as Month 1, with Physician Global Assessment scores falling approximately 75% from baseline by Month 6. Patient-reported fatigue scores improved approximately two-fold from baseline by Month 6. Deep B-cell depletion was followed by reconstitution of naïve B cells, and the 50 most abundant B-cell receptor clones at baseline were absent by Month 1 and did not re-emerge through Month 6.

The data are intended to support the ongoing RECLAIM-LN Phase 2 study (NCT07570862) in patients with refractory, moderate-to-severe SLE with lupus nephritis, which uses the same bendamustine conditioning regimen. According to the company's press release, FT819 is currently being administered in the outpatient setting in the United States.

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