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FHVH33-CD8BBZ is a fully human anti-BCMA (B cell maturation antigen) chimeric antigen receptor (CAR) T cell therapy that utilizes a heavy-chain-only antigen recognition domain (FHVH33), a CD8α hinge and transmembrane region, the 4-1BB (CD137) costimulatory domain, and the CD3ζ activation domain. Developed for the treatment of relapsed or refractory multiple myeloma, FHVH33-CD8BBZ T cells (termed FHVH-BCMA-T or FHVH-T) have shown powerful, rapid, and durable anti-myeloma activity in early phase clinical trials, including a 52% stringent complete response rate. The 4-1BB domain enhances T cell survival and persistence while mitigating activation-induced cell death. The product is manufactured using a γ-retroviral vector encoding the CAR construct and administered as autologous cell therapy following lymphodepleting chemotherapy. Key development has been led by the National Cancer Institute[1][2][3][5][8].
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