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Letetresgene autoleucel (lete-cel) is an investigational, affinity-enhanced, engineered T-cell receptor (TCR) cell therapy developed for the treatment of solid tumors expressing the cancer-testis antigen NY‑ESO‑1. The therapy involves isolating a patient’s own (autologous) T cells, genetically modifying them to express a high-affinity TCR specific for the NY‑ESO‑1 antigen presented by HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 molecules, and reinfusing them into the patient after lymphodepletion. Letetresgene autoleucel has demonstrated clinical benefit in patients with advanced or metastatic myxoid/round cell liposarcoma (MRCLS), particularly those who have received prior anthracycline-based chemotherapy and whose tumors are positive for both relevant HLA alleles and NY‑ESO‑1 expression. It is also being developed for synovial sarcoma. The drug has received FDA Breakthrough Therapy Designation for MRCLS[1][3][5][6][8]. The developer is Adaptimmune. AGC Biologics manufactures lentiviral vectors used in the manufacturing process.
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