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This is an investigational autologous cell therapy developed by the National Cancer Institute (NCI) Surgery Branch for the treatment of metastatic melanoma and metastatic renal cell carcinoma. The therapy involves the adoptive transfer of a patient's own natural killer (NK) cells, which are isolated via leukapheresis and expanded/activated ex vivo using OKT3 and interleukin-2 (IL-2). These NK cells are characterized as CD3-negative and CD56-positive lymphocytes capable of lysing tumor cells in a non-MHC-restricted manner. The treatment regimen typically includes lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by the infusion of the activated NK cells and subsequent high-dose aldesleukin (IL-2) to support cell persistence and activity. Clinical trials demonstrated that while the transferred NK cells could persist in circulation for weeks to months, they failed to produce objective clinical responses in patients who had previously failed IL-2 therapy.
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