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YK1101 is an investigational autologous T-cell receptor-engineered T-cell (TCR-T) therapy designed to treat advanced solid tumors expressing the melanoma-associated antigen-4 (MAGE-A4). Developed by Yingkai Saiwei, the therapy utilizes patient-derived T cells that are genetically modified to express a humanized high-affinity T-cell receptor (TCR) specific to MAGE-A4 peptides. A key differentiator of YK1101 is its restriction to the HLA-A*11:01 allele, which is highly prevalent in East Asian and Australasian populations, potentially providing a therapeutic option for patients not eligible for HLA-A*02-restricted therapies like afamitresgene autoleucel. Upon re-infusion, the engineered cells recognize MAGE-A4 peptide-MHC complexes on the surface of malignant cells, triggering T-cell activation and direct cytotoxic killing. YK1101 is currently being evaluated in Phase I clinical trials for various MAGE-A4-positive malignancies, including synovial sarcoma, urothelial carcinoma, and non-small cell lung cancer.
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