Definition

A preparation of autologous monocytes genetically modified to express a chimeric antigen receptor (CAR) specific for the tumor-associated antigen (TAA) human epidermal growth factor receptor 2 (HER2; ErbB2; HER-2), with potential immunostimulating and antineoplastic activities. Upon administration, autologous anti-HER2 CAR monocytes CT-0525 specifically recognize and bind to HER2-expressing tumor cells, and expose the immune system to the HER2 antigen. This may elicit a cytotoxic T-lymphocyte (CTL) response against HER2-expressing tumor cells. HER2 is overexpressed in a variety of cancer cell types and is associated with increased tumor cell proliferation.