Fate Therapeutics reports preliminary FT819 responses in lupus nephritis

• Fate Therapeutics (NASDAQ:FATE) reported preliminary Phase 1 results showing renal responses in both evaluable lupus nephritis patients treated with FT819 following bendamustine conditioning.
• The two patients achieved complete or primary efficacy renal responses at Month 6, with an approximately 50% mean reduction in urine protein-to-creatinine ratio. One patient's complete response persisted through Month 24.
• Across 29 patients treated for autoimmune diseases, no dose-limiting toxicities or deaths were reported. Fate is advancing FT819 through its potentially registrational Phase 2 RECLAIM-LN study.

Fate Therapeutics (NASDAQ:FATE) presented preliminary Phase 1 clinical results for FT819 showing renal responses in two evaluable patients with lupus nephritis, a serious kidney complication of systemic lupus erythematosus.

The findings were based on data collected through August 18, 2026, and presented at the American Society of Nephrology's Kidney Week 2026.

Both patients achieved a complete or primary efficacy renal response at Month 6 after receiving FT819 following bendamustine conditioning.

The patients also experienced an approximately 50% mean reduction in urine protein-to-creatinine ratio, a measure used to assess kidney damage. One patient's complete renal response persisted through Month 24.

The treatment results were observed after immunosuppressants were discontinued, although hydroxychloroquine and low-dose prednisone were permitted.

The findings provide preliminary evidence of sustained kidney-related responses, but the small number of evaluable patients limits conclusions about FT819's efficacy.

Across 29 patients treated with FT819 in autoimmune disease studies, Fate reported no dose-limiting toxicities or deaths.

Low-grade cytokine release syndrome occurred in five patients, while Grade 3 or higher infections and low blood-cell counts were reported in two and six patients, respectively.

Fate is advancing FT819 through RECLAIM-LN, an ongoing Phase 2 potentially registrational study evaluating the treatment in patients with refractory, moderate-to-severe systemic lupus erythematosus and Class III or IV lupus nephritis, with or without accompanying Class V disease.

The trial uses the same bendamustine conditioning regimen and is expected to enroll approximately 53 patients.

The study's primary endpoint is the proportion of patients achieving a complete renal response at Week 26. Secondary measures include later renal responses, disease activity, remission, quality of life and other patient-reported outcomes.

The trial follows regulatory discussions with the U.S. Food and Drug Administration under FT819's Regenerative Medicine Advanced Therapy designation.

FT819 is an investigational, off-the-shelf CAR T-cell therapy derived from induced pluripotent stem cells and designed to target CD19-positive B cells involved in autoimmune disease.

The Phase 1 findings support continued clinical evaluation, but larger studies will be needed to establish the treatment's safety, durability and effectiveness in lupus nephritis.