fostemogene autoleucel

Fostemogene autoleucel is a genetically modified autologous T‑cell therapy in which a patient’s own T cells are collected by leukapheresis, engineered ex vivo with a viral vector to express a tumor‑specific T‑cell receptor, expanded, and reinfused after lymphodepleting chemotherapy. It is being developed as a targeted cellular immunotherapy for cancer, designed to redirect CD4 and CD8 T cells against tumor cells presenting a defined peptide–HLA complex, leading to tumor cell recognition and cytotoxic killing. As a personalized cell therapy, its use requires specialized manufacturing and administration infrastructure, and its safety profile is expected to be dominated by cytokine release syndrome, neurotoxicity, and cytopenias typical of engineered T‑cell products.