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NeoTCR-P1 + nivolumab is an investigational combination therapy comprising a personalized, gene-edited autologous T cell receptor (TCR) T cell therapy (NeoTCR-P1) and nivolumab, a monoclonal antibody checkpoint inhibitor targeting programmed death-1 (PD-1). NeoTCR-P1 consists of CD8 and CD4 T cells derived from patient apheresis, genetically engineered to express an autologous TCR specific for a tumor-exclusive neoantigen presented by the patient's HLA molecules, enabling targeted recognition and destruction of tumor cells. Nivolumab blocks PD-1 on T cells, thereby enhancing T cell activity against cancer by preventing immune evasion. The combination aims to potentiate anti-tumor immune responses in patients with advanced or metastatic solid tumors. The combination is being tested in a Phase 1b clinical trial in multiple advanced solid tumor types including melanoma, urothelial cancer, colorectal cancer, ovarian cancer, hormone receptor–positive breast cancer, and prostate cancer.
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