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Interleukin-2 gene therapy refers to gene therapy strategies involving the in vivo delivery of DNA or other genetic material encoding interleukin-2 (IL-2), a cytokine critical for T cell growth and immune system regulation, directly into a patient’s cells. The intent is for target cells to express and secrete IL-2 locally at the disease site, most often tumors, thereby stimulating immune cell activation and anti-tumor responses. The IL-2 protein engages its receptor (consisting of IL-2R alpha, IL-2R beta, and IL-2R gamma subunits) on lymphocytes, leading to proliferation and activation of cytotoxic T lymphocytes and natural killer (NK) cells. In cancer, this approach potentially increases the immune system’s ability to attack tumor cells, while reducing the systemic toxicity seen with recombinant IL-2 protein therapy. This is a gene therapy modality, distinct from pharmacologic recombinant IL-2 administration or engineered protein/antibody therapies. As of 2025, IL-2 gene therapies are primarily in experimental or investigational stages and have not yet received regulatory approval for specific indications, but clinical research continues in oncology and, to a lesser extent, in autoimmune disease contexts[1][4][9].
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