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HER2-specific CD4+ T-cell therapy is an investigational adoptive cell therapy being developed by the H. Lee Moffitt Cancer Center and Research Institute for the treatment of metastatic HER2-positive breast cancer. The therapy consists of autologous CD4+ Th1 cells that are expanded ex vivo using cytokines such as IL-15 and IL-7 to target the Human Epidermal Growth Factor Receptor 2 (HER2). In clinical protocols, this T-cell infusion is administered as part of a combinatorial regimen following a HER2-pulsed dendritic cell (DC1) vaccine, which serves to prime the immune system. The regimen also incorporates the monoclonal antibodies trastuzumab and pepinemab to enhance the infiltration and activity of the infused T cells within the tumor microenvironment. This multi-modal approach aims to overcome immune evasion and provide a durable anti-tumor response in patients with advanced HER2-expressing malignancies.
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