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TAC01-HER2 (fencabtagene autoleucel) is a genetically engineered, autologous T-cell therapy designed to target human epidermal growth factor receptor 2 (HER2/ERBB2) on tumor cells. The therapy uses the T-cell Antigen Coupler (TAC) technology, which modifies a patient's own T cells to express a synthetic receptor that binds HER2 and activates endogenous T cell receptor signaling upon engagement. This mechanism aims to direct potent and specific cytotoxic activity against HER2-expressing tumor cells while minimizing off-target toxicity compared to traditional CAR-T therapies. TAC01-HER2 is being developed primarily for the treatment of relapsed or refractory HER2-positive solid tumors—including gastric and gastroesophageal junction adenocarcinoma—and has shown early clinical activity with a manageable safety profile in phase 1/2 trials. The developer is Tacitus Therapeutics[1][3][4][5][6][7].
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