Definition

A preparation of human autologous T-lymphocytes transduced with a viral vector encoding for a T cell receptor (TCR) specific for a human hepatitis B virus (HBV) surface antigen (HBsAg), with potential antineoplastic activity. Following administration, the autologous HBV antigen specific TCR-redirected autologous T lymphocytes recognize and bind to the HBV antigen-positive cells, which induces cytotoxic T-lymphocyte (CTL)-mediated elimination of HBV antigen-positive cancer cells. HBV antigens are found on HBV-positive cells and HPV-induced hepatocellular carcinoma (HCC).