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TM001 is an autologous tumor-infiltrating lymphocyte (TIL) therapy developed by the Netherlands Cancer Institute (NKI) for the treatment of advanced melanoma. The therapy involves the isolation of naturally occurring T cells from a patient's tumor tissue, which are then expanded ex vivo to create a large population of tumor-reactive lymphocytes. These cells are re-infused into the patient following a non-myeloablative lymphodepleting chemotherapy regimen. The infusion is typically followed by high-dose interleukin-2 (IL-2) to support the survival, expansion, and anti-tumor activity of the TILs in vivo. TM001 is currently provided under a hospital exemption (HE) program in the Netherlands for patients who have progressed on immune checkpoint inhibitors, such as anti-PD-1 and anti-CTLA-4 therapies, following positive results from a randomized phase III trial.
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