San Diego, California — August 14, 2026
Fate Therapeutics, Inc. has initiated the potentially registrational RECLAIM-LN Phase 2 clinical trial of FT819, an off-the-shelf CAR T-cell therapy candidate, in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis. The company also reported that the first patient has been dosed in an outpatient setting and discharged the same day, marking an important development in the clinical advancement of FT819 for serious autoimmune disease. The trial is designed to evaluate whether a single dose of FT819 can provide meaningful renal responses in patients who have exhausted multiple prior immunosuppressive treatments. The study is expected to enroll approximately 53 patients with Class III or IV lupus nephritis, with enrollment anticipated to be completed within 15–18 months, by the first half of 2028.
RECLAIM-LN Evaluates Off-the-Shelf CAR T Therapy
Fate Therapeutics is advancing FT819 through the RECLAIM-LN study as a potential treatment for patients with difficult-to-treat lupus nephritis. The multicenter, open-label, single-arm Phase 2 trial will enroll patients whose disease remains refractory after at least two prior systemic immunosuppressive therapies. Participants will receive a single 900-million-cell dose of FT819 following less-intensive conditioning with bendamustine. The study’s primary endpoint is complete renal response at Week 26, while additional assessments will examine renal response at later timepoints, overall and partial renal response, disease activity, remission, quality of life and patient-reported outcomes. The initiation of the trial represents a significant step for the company as it evaluates whether its iPSC-derived, off-the-shelf CAR T-cell platform can provide a scalable cellular immunotherapy approach for autoimmune disease.
FDA Support Strengthens FT819 Development Pathway
The RECLAIM-LN trial was developed through interactions with the U.S. Food and Drug Administration (FDA) under the Regenerative Medicine Advanced Therapy (RMAT) designation granted to FT819. The program has also been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, providing opportunities for enhanced regulatory interaction related to manufacturing and CMC readiness. Fate Therapeutics said the clinical development strategy builds on findings from its Phase 1 program, where FT819 demonstrated a favorable safety and tolerability profile along with improvements across disease activity measures. The company highlighted reductions in SLEDAI-2K and urine protein-to-creatinine ratio (UPCr), with further improvements observed when less-intensive bendamustine conditioning was used. These earlier findings are supporting the company’s continued evaluation of FT819 in the more advanced RECLAIM-LN program.
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FT819 Targets Broader Access to Cellular Therapy
FT819 is an investigational CD19-targeting CAR T-cell therapy manufactured from a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank. Unlike conventional patient-specific CAR T-cell approaches, FT819 is being developed as an off-the-shelf cellular therapy, with the potential to be manufactured in advance, stored in inventory and administered when needed. Fate Therapeutics believes this approach could address some of the logistical and manufacturing limitations associated with patient- or donor-derived cellular therapies. The company is developing FT819 as part of its broader iPSC-derived cellular immunotherapy platform, which includes engineered T-cell and natural killer (NK) cell candidates. With the first patient now treated in RECLAIM-LN and enrollment underway across activated clinical sites, the program moves into an important phase of clinical development focused on determining the efficacy and safety of FT819 in lupus nephritis and its potential to support a future accelerated regulatory pathway.
Source: Fate Therapeutics press relese
