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CT-0508 is a first-in-class, autologous chimeric antigen receptor macrophage (CAR-M) therapy targeting human epidermal growth factor receptor 2 (HER2). It is manufactured from a patient’s own peripheral blood monocytes, which are engineered ex vivo to express an anti-HER2 CAR and then differentiated into M1-polarized macrophages. Upon infusion, these cells are designed to recognize and bind HER2-expressing tumor cells, mediate direct phagocytosis and cytotoxicity, remodel the tumor microenvironment (TME), activate endogenous T-cell responses through antigen presentation and cytokine release, and promote expansion of CD8+ T cells within the TME. The therapy aims to overcome limitations of existing cell therapies in solid tumors by leveraging the innate immune functions of macrophages. Developed by Carisma Therapeutics in collaboration with researchers at the University of Pennsylvania, CT-0508 has received FDA Fast Track designation for solid tumors overexpressing HER2[1][3][4][5][6][7][9][10].
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