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 following less-intensive conditioning with bendamustine; complete renal response at Week 26 is the primary endpoint
Aug. 14, 2026 -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today highlighted the initiation of and treatment of the first patient in RECLAIM-LN (NCT07570862), its Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis.
“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. “The study design reflects our interactions with the FDA under FT819 RMAT designation and builds on the clinical activity, favorable safety pro patient accessibility observed to date in our Phase 1 program. Early interest from investigators in the lupus nephritis community has been encouraging as we ramp up enrollment.”
RECLAIM-LN (FT819-201; NCT07570862) is a multicenter Phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of FT819 in patients with refractory moderate-to-severe SLE with Class III or IV lupus nephritis (with or without concomitant class V). One of the most serious manifestations of SLE, lupus nephritis, is a leading driver of kidney failure among patients with lupus, many of whom have exhausted available immunosuppressive treatment options. The study is expected to enroll approximately 53 patients who are refractory to at least two prior systemic immunosuppressive therapies. The primary endpoint is the proportion of participants achieving complete renal response (CRR) at Week 26. Secondary endpoints include evaluation of CRR at later timepoints, overall and partial renal response, lupus low disease activity state, remission, quality of life measures, and other disease-related and patient-reported outcomes. Preliminary data from the Phase 1 study demonstrated favorable safety and tolerability and clinically meaningful improvement with sustained improvements across several disease activity measures, including clinical Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K and urine protein-to-creatinine ratio (UPCr). Both measures showed further reductions with the use of less-intensive bendamustine conditioning.
The RECLAIM-LN study was developed through interactions with the FDA under FT819 Regenerative Medicine Advanced Therapy (RMAT) designation. FT819 has also been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, which provides opportunities for early and enhanced communication with the FDA regarding CMC readiness for therapies with accelerated clinical development timelines.
FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303)
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA.
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