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This experimental immunotherapy regimen, developed by the National Cancer Institute (NCI), combines adoptive cell transfer of genetically modified T-cells with high-dose cytokine support for the treatment of HER2-positive metastatic cancers. Patient-derived peripheral blood lymphocytes (PBLs) are harvested and transduced with a retroviral vector encoding a chimeric antigen receptor (CAR) specific for the Human Epidermal Growth Factor Receptor 2 (HER2/neu) antigen. Following a lymphodepleting conditioning regimen of cyclophosphamide and fludarabine, the engineered CAR T-cells are infused back into the patient. This is followed by the administration of high-dose aldesleukin (recombinant interleukin-2) to promote the in vivo expansion, activation, and persistence of the modified T-cells. The therapy is designed to leverage the specificity of the CAR to target and eliminate HER2-expressing tumor cells throughout the body.
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