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This experimental adoptive cell therapy, developed by the National Cancer Institute (NCI), consists of autologous peripheral blood lymphocytes (PBLs) that have been retrovirally transduced to express both a high-affinity T-cell receptor (TCR) specific for the NY-ESO-1 cancer-testis antigen and the cytokine interleukin-12 (IL-12). The TCR is HLA-A*0201-restricted, allowing the engineered T cells to recognize and target NY-ESO-1-expressing metastatic cancer cells. The co-expression of IL-12 is intended to enhance the anti-tumor activity, persistence, and effector function of the T cells within the tumor microenvironment, potentially eliminating the need for systemic high-dose IL-2 administration. This investigational therapy was evaluated in a Phase I clinical trial (NCT01457131) for patients with metastatic cancers, including melanoma and renal cell carcinoma, but development was terminated due to significant toxicities observed during the study.
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