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BT004 is an autologous T-cell receptor-engineered T-cell (TCR-T) therapy designed to target solid tumors harboring KRAS G12V or G12D mutations. Developed by Sun Yat-sen University, this biologic therapy involves genetically modifying a patient's own T cells to express specific T-cell receptors that recognize mutant KRAS neoantigen peptides presented by Human Leukocyte Antigen (HLA) molecules on the surface of cancer cells. By targeting these specific intracellular oncogenic mutations, BT004 aims to provide a precision immunotherapy approach for common cancers such as pancreatic, colorectal, and non-small cell lung cancers that frequently carry these KRAS variants. The therapy is currently being evaluated in Phase 1 clinical trials for safety and efficacy in patients with advanced solid tumors.
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