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  • A preparation of autologous T-lymphocytes engineered to express two separate chimeric antigen receptors (CARs) targeting the tumor-associated antigens (TAAs) BCMA and CD19 and fused to as of yet not fully elucidated co-stimulatory domains, with potential immunostimulating and antineoplastic activities. Upon administration, the autologous bispecific BCMA/CD19-targeted CAR-T cells GC012F specifically and simultaneously target and bind to tumor cells expressing BCMA and/or CD19. This induces selective toxicity in tumor cells that express BCMA and/or CD19. BCMA, a tumor-specific antigen and a receptor for both a proliferation-inducing ligand (APRIL) and B-cell activating factor (BAFF), is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and plays a key role in the survival of B-lymphocytes and plasma cells. BCMA is found on the surfaces of B-cells and is overexpressed on malignant plasma cells. CD19 is a B-cell-specific cell surface antigen overexpressed in B-cell lineage malignancies. The processing platform used, FasT CAR-T, shortens the manufacturing time to produce the CAR-T cells within 24 hours.
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