07:41 AM EDT, 08/14/2026 (MT Newswires) -- Fate Therapeutics ( FATE ) said Friday that it initiated its phase 2 RECLAIM-LN trial and treated the first patient with FT819, an off-the-shelf CAR T-cell therapy candidate, in refractory moderate-to-severe systemic lupus erythematosus with lupus nephritis.
The potentially registrational trial is expected to enroll about 53 patients who have failed at least two prior systemic immunosuppressive therapies, it said. The primary endpoint is the proportion of patients achieving complete renal response at Week 26, it added.
Fate said the study was developed through discussions with the FDA under FT819's Regenerative Medicine Advanced Therapy designation. Preliminary phase 1 data showed favorable safety and tolerability, it added.