Definition

A preparation of autologous macrophages transduced with the adenoviral vector Ad5f35 to express a chimeric antigen receptor (CAR) targeting the tumor-associated antigen (TAA) human epidermal growth factor receptor 2 (EGFR2; HER2; ErbB2), with potential immunostimulatory and antineoplastic activities. Upon administration, autologous anti-HER2 CAR Macrophages (CAR-M) CT-0508 specifically recognize and bind to HER2-expressing tumor cells, resulting in the phagocytosis of HER2-expressing tumor cells. CAR-M CT-0508 maintain the pro-inflammatory, anti-tumor M1 phenotype within the human tumor microenvironment (TME). In addition, CAR-M CT-0508 may activate an anti-tumor T-lymphocyte immune response resulting in T-cell-mediated killing of tumor cells. HER2, a receptor tyrosine kinase that is mutated or overexpressed in many tumor cell types, plays an important role in tumor cell proliferation and tumor vascularization.