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This investigational adoptive cell therapy (ACT) is a multi-component regimen developed by the H. Lee Moffitt Cancer Center and Research Institute for the treatment of metastatic melanoma. The core of the therapy involves autologous tumor-infiltrating lymphocytes (TILs), which are T cells harvested from a patient's own tumor, expanded to large numbers ex vivo, and then reinfused. The specific protocol (evaluated in trial NCT01701674) combines these TILs with a priming dose of the CTLA-4 checkpoint inhibitor ipilimumab to enhance T-cell activity, followed by a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine. After TIL infusion, patients receive high-dose interleukin-2 (IL-2) to promote the survival and proliferation of the transferred cells. This approach aims to overcome the immunosuppressive tumor microenvironment and provide a robust, tumor-reactive immune response.
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