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TBI-2001 is an investigational, allogeneic adoptive cell therapy consisting of natural killer (NK) cells engineered to express a T-cell receptor (TCR) specific for the Melanoma-Associated Antigen A4 (MAGE-A4). Developed by Takara Bio, the therapy utilizes NK cells that are modified to express a TCR recognizing MAGE-A4 peptides presented by HLA-A*24:02 on the surface of cancer cells. This TCR-NK approach aims to combine the antigen-targeting precision of TCRs—which can recognize intracellular tumor antigens—with the innate cytotoxic potential and favorable safety profile of NK cells, potentially providing an off-the-shelf treatment option. TBI-2001 is currently being evaluated in clinical trials for the treatment of MAGE-A4-positive solid tumors, such as synovial sarcoma and various carcinomas.
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