Fate Therapeutics starts potentially registrational Phase 2 RECLAIM-LN trial of FT819 in lupus nephritis

Fate Therapeutics started RECLAIM-LN, a Phase 2 potentially registrational study of FT819 in lupus nephritis; the first patient has been dosed.

Results have not been presented; the trial is designed to support a potential accelerated regulatory path tied to an RMAT designation.

The study will assess whether a single dose can drive meaningful kidney improvement in refractory moderate-to-severe SLE with Class III or IV disease.

Enrollment targets 53 patients; completion is projected in 15-18 months, by 1H2028.