Fate Therapeutics Launches CAR T Trial for Lupus Nephritis
The Phase 2 study will enroll about 53 patients to evaluate a single off-the-shelf CAR T-cell dose, with complete renal response at Week 26 as the primary endpoint.
Key Points
- Fate Therapeutics has dosed the first patient in its potentially registrational Phase 2 RECLAIM-LN trial of FT819 for lupus nephritis.
- The study will enroll about 53 patients and assess complete renal response at Week 26 as its primary endpoint.
- Patients will receive one 900 million-cell dose of off-the-shelf FT819 after less-intensive conditioning with bendamustine.
Fate Therapeutics has launched RECLAIM-LN, a Phase 2 trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) and lupus nephritis. The first patient received treatment in an outpatient setting and was discharged the same day. Multiple patients are screening at several activated trial sites.
“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 profile and 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 Trial Design
RECLAIM-LN, also identified as FT819-201 and NCT07570862, is a multicenter, open-label, single-arm trial. It will enroll approximately 53 patients with Class III or IV lupus nephritis, with or without concomitant Class V disease. Eligible patients must have received at least two prior systemic immunosuppressive therapies without an adequate response.
Lupus nephritis is a serious manifestation of SLE that can lead to kidney failure. The study is intended for patients whose disease has not responded to available immunosuppressive treatments.
The trial will evaluate:
- Complete renal response at Week 26 as the primary endpoint
- Complete renal response at later time points
- Overall and partial renal response
- Lupus low disease activity state and remission
- Quality of life measures
- Other disease-related and patient-reported outcomes
Fate expects enrollment to take 15 to 18 months and to be completed by the first half of 2028.
The company reports that preliminary Phase 1 data showed favorable safety and tolerability, along with sustained improvements in clinical Systemic Lupus Erythematosus Disease Activity Index 2000 scores and urine protein-to-creatinine ratio. Both measures showed additional reductions among patients who received less-intensive bendamustine conditioning.
Off-the-Shelf CAR T-Cell Manufacturing
FT819 is an off-the-shelf, CD19-targeting chimeric antigen receptor (CAR) T-cell candidate. It is manufactured from a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank rather than collecting cells from each patient or donor.
Fate says this manufacturing approach produces a defined and consistent cell product that can be stored in inventory for on-demand treatment. The company is developing the approach to address manufacturing and access limitations associated with patient-sourced and donor-derived CAR T-cell therapies.
The FDA granted FT819 Regenerative Medicine Advanced Therapy designation. The candidate was also selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program, which provides additional communication with the agency about manufacturing readiness during accelerated clinical development.
The California Institute for Regenerative Medicine supported the research through grant CLIN2-16303.
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