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Anti-HER2 CAR-monocytes are a novel cell therapy in which human monocytes are genetically engineered to express a chimeric antigen receptor (CAR) that targets the HER2 antigen. Upon administration, these CAR-modified monocytes specifically recognize and bind to HER2-expressing tumor cells, resulting in direct tumor cell phagocytosis, induction of pro-inflammatory cytokines, antigen presentation, and subsequent activation of the adaptive immune response, including cytotoxic T-cell responses. In preclinical studies, anti-HER2 CAR-monocytes have demonstrated potent anti-tumor activity against HER2+ solid tumors (e.g., breast and ovarian cancer) by secreting inflammatory cytokines such as TNFα, IL-1β, IL-6, and degrading extracellular matrix through upregulation of matrix metalloproteinases (MMP13), thereby enhancing immune cell infiltration. The most advanced version in development is the autologous CT-0525 product. The therapeutic approach leverages monocyte/macrophage biology, including their capacity for antigen presentation and remodeling the tumor microenvironment. Anti-HER2 CAR-monocytes are in preclinical and early clinical development for HER2-positive solid tumors[1][2][3][4][5][6][7].
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