Fate Therapeutics, Inc. (NASDAQ: FATE) has dosed the first patient in RECLAIM-LN (NCT07570862), a Phase 2 potentially registrational clinical trial evaluating FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis, according to a press release from the company.

The first patient was treated in an outpatient setting and discharged the same day. Multiple patients are in the process of screening at several activated sites. The study is expected to enroll approximately 53 patients who are refractory to at least two prior systemic immunosuppressive therapies, with enrollment anticipated to complete within 15 to 18 months, by the first half of 2028.

Patients will receive a single 900 million-cell dose of FT819 following conditioning with bendamustine. The primary endpoint is the proportion of participants achieving complete renal response at Week 26. Secondary endpoints include overall and partial renal response, lupus low disease activity state, remission, and quality of life measures.

FT819 is an off-the-shelf CD19-targeting CAR T-cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) bank. The trial was developed through interactions with the FDA under FT819's Regenerative Medicine Advanced Therapy (RMAT) designation. FT819 has also been selected for the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.

"The initiation of RECLAIM-LN and treatment of the first patient marks an important step in our effort to establish FT819 as a broadly accessible, off-the-shelf CAR T-cell therapy for patients with serious autoimmune disease," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics.

Fate Therapeutics is headquartered in San Diego, California. Funding for FT819 research was partially provided by the California Institute for Regenerative Medicine under grant number CLIN2-16303.