Fate Therapeutics starts Phase 2 lupus nephritis trial of FT819

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Go back to Fate Therapeutics starts Phase 2 lupus nephritis trial of FT819

Fate Therapeutics Initiates Potentially Registrational RECLAIM-LN Clinical Trial of FT819 for the Treatment of Lupus Nephritis

August 14, 2026 7:00 AM EDT

First patient dosed in an outpatient setting, discharged the same day; multiple patients in the process of screening at several activated sites

Trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and Readiness Pilot program

Study expected to enroll approximately 53 patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with Class III or IV lupus nephritis; study anticipated to complete enrollment in 15-18 months, by 1H2028

Patients to receive a single 900 million-cell dose of off-the-shelf FT819... More