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FT536 is an allogeneic, off-the-shelf, multiplexed-engineered chimeric antigen receptor (CAR) natural killer (NK) cell therapy derived from induced pluripotent stem cells (iPSC). It is designed to target the α3 domain of the pan-tumor associated stress proteins MICA and MICB, which are commonly expressed on solid tumors. The product incorporates four functional elements: a novel CAR targeting MICA/MICB to overcome proteolytic shedding and restore immune recognition; a high-affinity 158V, non-cleavable CD16 Fc receptor to enhance antibody-dependent cellular cytotoxicity; an IL-15 receptor fusion protein to augment NK cell activity; and knockout of the CD38 gene for improved persistence in hostile tumor microenvironments. Developed by Fate Therapeutics under license from Dana-Farber Cancer Institute, FT536 was evaluated in Phase 1 clinical trials for advanced solid tumors as monotherapy or in combination with monoclonal antibodies[2][4][5][6][7][8]. Its development was discontinued after termination of its Phase 1 clinical trial for solid tumors due to sponsor decision.
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