FT819 - (RECLAIM-LN)

Aug. 14, 2026: Fate Therapeutics (NASDAQ: FATE) announced initiation of RECLAIM-LN (FT819-201; NCT07570862), a Phase 2 potentially registrational trial of FT819, and dosing of the first patient in an outpatient setting with same-day discharge. FT819 is an off-the-shelf CD19-targeting CAR T-cell therapy being studied in refractory moderate-to-severe systemic lupus erythematosus with Class III or IV lupus nephritis (with or without concomitant class V).

The open-label, single-arm multicenter study is expected to enroll about 53 patients refractory to at least two prior systemic immunosuppressive therapies. Patients receive a single 900 million-cell dose after less-intensive bendamustine conditioning. The primary endpoint is complete renal response at Week 26; secondary endpoints include later complete renal response, overall/partial renal response, lupus low disease activity state, remission, quality of life, and other disease-related and patient-reported outcomes.

The company said enrollment is anticipated to complete in 15-18 months, by 1H2028, with multiple patients screening at several activated sites. Fate said the trial was developed through FDA interactions under FT819’s RMAT designation, and that FT819 is also in the FDA CMC Development and Readiness Pilot program, which the company says may support an accelerated regulatory pathway. Preliminary Phase 1 data cited favorable safety/tolerability and sustained improvements in SLEDAI-2K and urine protein-to-creatinine ratio, with further reductions using bendamustine conditioning.