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FT819 + cyclophosphamide is an investigational combination regimen consisting of FT819, an off-the-shelf, induced pluripotent stem cell (iPSC)-derived, CD19-targeted chimeric antigen receptor (CAR) T-cell therapy, and cyclophosphamide, a small-molecule alkylating chemotherapy used as a lymphodepleting conditioning agent. Developed by Fate Therapeutics, this fludarabine-free regimen is designed to deplete disease-causing CD19-positive B cells and allow a healthy immune system to rebuild. It is primarily being evaluated in a Phase 1 clinical trial (NCT06308978) for the treatment of moderate-to-severe B-cell-mediated autoimmune diseases, including systemic lupus erythematosus (SLE), lupus nephritis, systemic sclerosis, idiopathic inflammatory myositis, and ANCA-associated vasculitis.
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