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This is an investigational autologous adoptive cell therapy developed by the H. Lee Moffitt Cancer Center and Research Institute for the treatment of metastatic melanoma. The therapy involves extracting tumor-infiltrating lymphocytes (TILs) from a patient's own tumor tissue and expanding them ex vivo. A distinguishing feature of this specific TIL product is the use of an anti-4-1BB (CD137) agonistic antibody during the laboratory culture process to augment T-cell proliferation, fitness, and anti-tumor activity. Following a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine, the expanded TILs are re-infused into the patient, typically followed by high-dose interleukin-2 (IL-2) to support T-cell survival and expansion in vivo. In clinical trials, this therapy has been evaluated in combination with the PD-1 inhibitor nivolumab, demonstrating safety and feasibility in treatment-naïve patients with unresectable stage III/IV melanoma.
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