Definition

A preparation of autologous T lymphocytes that are genetically engineered with a T-cell Antigen Coupler (TAC), comprising of a domain that targets the tumor-associated antigen (TAA) human epidermal growth factor receptor 2 (HER2) and another domain that binds to the endogenous T-cell receptor (TCR), with potential immunostimulating and antineoplastic activities. Upon administration, autologous anti-HER2 TAC T cells TAC01-HER2 targets and binds to HER2-expressing tumor cells and activates TCR-mediated signaling pathways, leading to T-cell-mediated killing of HER2-expressing tumor cells. HER-2, a tyrosine kinase receptor for epidermal growth factor (EGF) (also known as neu and ErbB2), is overexpressed by a variety of cancers.