Fate Therapeutics has initiated and treated the first patient in RECLAIM-LN, a Phase II clinical trial evaluating FT819 in patients with moderate-to-severe systemic lupus erythematosus (SLE) with Class III or IV lupus nephritis.
The first patient in the study received treatment as an outpatient and was discharged the same day. Multiple additional patients are currently undergoing screening at several activated trial sites.
The single-arm, multi-centre, open-label trial aims to assess the efficacy and safety of FT819 in a population who have not responded to at least two prior systemic immunosuppressive therapies.
It will enrol around 53 participants and aims to conclude enrolment within 15 to 18 months, with completion anticipated in the first half of 2028.
Each participant will receive a single 900 million-cell dose of FT819 following less-intensive conditioning with bendamustine. The study’s primary endpoint is the proportion of patients achieving a complete renal response at 26 weeks.
The study design incorporates feedback from Fate Therapeutics’ interactions with the US Food and Drug Administration (FDA) under Regenerative Medicine Advanced Therapy (RMAT) designation for FT819.
The product has also been included in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot programme, which is aimed at supporting therapies on accelerated clinical pathways.
Fate Therapeutics president and CEO Bob Valamehr said: “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.”
Preliminary data from a Phase I trial indicated that FT819 was well tolerated and led to improvements in disease activity, including reductions in the clinical Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K and urine protein-to-creatinine ratio.
The trial is supported by funding from the California Institute for Regenerative Medicine.
In January 2024, Fate Therapeutics begun a Phase I clinical trial of its chimeric antigen receptor (CAR) T-cell therapy, FT825 / ONO-8250, to potentially treat advanced solid tumours.
