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OKT3 + interleukin-2 is an investigational combination therapy consisting of the murine monoclonal antibody OKT3 (anti-CD3) and recombinant human interleukin-2 (IL-2). OKT3 targets the CD3 antigen on T lymphocytes and is primarily used as an immunosuppressive agent to prevent or treat allograft rejection. At lower doses in oncology settings, it can activate T cells. Interleukin-2 is a cytokine that stimulates proliferation and activation of lymphocytes, particularly T cells and natural killer (NK) cells. The rationale for combining these agents is to enhance immune-mediated antitumor activity by first activating T cells with OKT3 and then expanding them with IL-2. Clinical studies have evaluated this combination in patients with advanced cancers such as melanoma and renal cell carcinoma who had failed prior therapies. While some increases in activated lymphocyte populations were observed, objective tumor responses were limited; toxicities included neurotoxicity from high-dose OKT3 and typical side effects associated with high-dose IL-2[1][2][3][4]. The combination has not demonstrated clear superiority over IL-2 alone in clinical trials.
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