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**anti-NY-ESO-1 TCR-T** is an investigational autologous cell therapy comprising T cells genetically engineered to express a high-affinity T cell receptor (TCR) specific for the cancer-testis antigen **NY-ESO-1**. These TCR-T cells recognize and target NY-ESO-1 presented by HLA-A*02:01 on tumor cells, enabling selective cytotoxic immune responses against NY-ESO-1-expressing malignancies, notably synovial sarcoma, soft tissue sarcoma, and non-small cell lung cancer[1][2][4]. TAEST16001 is a notable formulation, utilizing affinity enhancement by phage display mutation in TCR CDRs for optimal specificity and safety, delivered after lymphodepletion with fludarabine and cyclophosphamide, and maintained post-infusion with low-dose IL-2[1][2]. Phase 1 and phase 2 trials have demonstrated objective response rates of 41–61% in advanced sarcoma and NSCLC patients, with manageable safety profile and moderate rates of cytokine release syndrome[1][2]. The therapy is under development for multiple NY-ESO-1-positive solid malignancies.
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