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KSV01 is an autologous, third-generation chimeric antigen receptor (CAR) T-cell therapy designed to target the B-lymphocyte antigen CD19. The therapy utilizes a self-inactivating lentiviral vector to genetically engineer a patient's own T cells to express a CAR specifically directed against CD19, a protein widely expressed on the surface of most B-cell malignancies. As a third-generation CAR-T product, KSV01 typically incorporates two costimulatory signaling domains (such as CD28 and 4-1BB) along with the CD3-zeta activation domain to potentially enhance T-cell expansion, persistence, and anti-tumor efficacy compared to earlier generations. It is currently under clinical investigation in Phase 1 trials for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL).
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