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F01 is an investigational cell therapy consisting of natural killer (NK) cells engineered to express a chimeric antigen receptor (CAR) targeting the CD19 antigen. Developed by RenJi Hospital (affiliated with Shanghai Jiao Tong University School of Medicine), F01 is being evaluated for the treatment of various refractory autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis, and inflammatory myopathies. The therapy aims to deplete B cells, which play a central role in the pathogenesis of these conditions, by leveraging the cytotoxic potential of NK cells. Unlike CAR-T cell therapies, CAR-NK cells may offer a more favorable safety profile with a lower risk of cytokine release syndrome (CRS) and neurotoxicity. The treatment protocol typically involves a lymphodepletion preconditioning regimen with fludarabine and cyclophosphamide prior to the infusion of the CAR-NK cells.
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