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TP53 R248Q TCR-T cells are an autologous T cell receptor–engineered T cell therapy designed to target the recurrent cancer-associated TP53 R248Q missense mutation presented on HLA-A*11:01 in patients with advanced solid tumors. Patient T cells are collected, genetically modified ex vivo to express a high-affinity TCR specific for the TP53 R248Q-derived peptide in complex with HLA-A*11:01, expanded, and reinfused to mediate selective recognition and lysis of TP53 R248Q-mutant tumor cells while sparing normal tissues lacking this neoantigen.[2][5][6][7][9] Preclinical studies have shown potent anti-tumor activity in vitro and in patient-derived xenograft models, and an early phase 1 investigator-initiated clinical trial in China (NCT06619886) is evaluating safety, tolerability, and preliminary efficacy in a range of advanced solid tumors harboring TP53 R248Q and HLA-A*11:01.[2][5][7]
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