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This multi-component adoptive cell therapy (ACT) regimen consists of a lymphodepleting conditioning phase followed by the infusion of autologous tumor-infiltrating lymphocytes (TILs) and subsequent interleukin-2 (IL-2) support. Developed and extensively studied by Inge Marie Svane at the National Center for Cancer Immune Therapy (CCIT) in Denmark, the protocol utilizes cyclophosphamide and fludarabine to create a favorable homeostatic environment by depleting endogenous lymphocytes and regulatory T cells. The TILs, which are expanded ex vivo from a patient's resected tumor tissue, are then infused to target and eliminate melanoma cells by recognizing tumor-associated antigens. High-dose or low-dose IL-2 (aldesleukin) is administered post-infusion to enhance the expansion and persistence of the transferred T cells in vivo. This regimen demonstrated a significant progression-free survival benefit over ipilimumab in a landmark Phase 3 trial for patients with unresectable stage III or IV melanoma.
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