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FH-MagIC TCR-T cells are an autologous T cell receptor–engineered T cell therapy in which a patient’s own CD8+ and CD4+ T cells are transduced ex vivo with a high-affinity transgenic TCR specific for a class I HLA-A*02:01–restricted epitope of the cancer-testis antigen MAGE-A1, then expanded and reinfused to target MAGE-A1–expressing solid tumors including metastatic urothelial carcinoma, triple-negative breast cancer, and non-small cell lung cancer.[1] MAGE-A1 is broadly expressed across multiple malignancies but absent from most normal tissues except immune-privileged testes, providing a tumor-selective target for TCR-based adoptive cell therapy.[1] In a Phase I/II trial (NCT04639245), FH-MagIC TCR-T is being evaluated alone and in combination with standard-of-care anti–PD-(L)1 therapy, typically after lymphodepleting chemotherapy with cyclophosphamide and fludarabine, with primary objectives of assessing safety and radiographic response and secondary endpoints including progression-free survival, overall survival, and persistence and tumor trafficking of the engineered T cells.[1]
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