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BMS-986353 is an investigational CD19-directed chimeric antigen receptor (CAR) T cell therapy being developed by Bristol Myers Squibb. It's manufactured using the NEX-T process, which is designed to shorten manufacturing time, improve potency, and optimize phenotypic attributes of the CAR T cell product. The therapy utilizes the same CAR construct as lisocabtagene maraleucel (liso-cel), an FDA-approved CAR T therapy, but with manufacturing improvements. BMS-986353 is currently being evaluated in Phase 1 clinical trials for various autoimmune diseases including systemic lupus erythematosus (SLE), multiple sclerosis (MS), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM), as well as for relapsed or refractory B-cell non-Hodgkin lymphoma. BMS-986353 works by targeting CD19, a protein expressed on B cells and plasmablasts, which play a key role in the pathogenesis of autoimmune diseases. The therapy is designed to achieve deep B-cell depletion, potentially "resetting" the immune system in patients with autoimmune conditions. The CAR construct includes a 41BB co-stimulatory domain and an epidermal growth factor receptor safety switch. After a single infusion following lymphodepletion, the engineered T cells expand in the body and target CD19-positive cells.
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