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FT819 + bendamustine is an investigational combination regimen consisting of FT819, an off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T-cell therapy, and bendamustine, an alkylating chemotherapy agent used for lymphodepleting conditioning. Developed by Fate Therapeutics, FT819 is derived from a clonal, T-cell receptor (TCR)-knockout induced pluripotent stem cell (iPSC) master cell line and engineered to target CD19 on B cells. The CAR transgene is integrated directly into the T-cell receptor alpha constant (TRAC) locus and utilizes a 1XX CAR signaling domain to enhance potency and prevent exhaustion. Bendamustine is administered prior to FT819 infusion to deplete host lymphocytes, replacing traditional fludarabine-based conditioning which can be problematic in patients with renal impairment. This combination is primarily being evaluated for the treatment of moderate-to-severe systemic lupus erythematosus (SLE), including refractory lupus nephritis.
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