Definition

A preparation of human autologous T lymphocytes that are transduced with a lentiviral vector (LV) encoding an affinity-enhanced T-cell receptor (TCR) specific for the cancer-testis antigen NY-ESO-1, with potential immunostimulating and antineoplastic activities. Upon isolation, transduction, expansion ex vivo, and reintroduction into the patient, the anti-NY-ESO-1 TCR LV-transduced autologous T cells TAEST16001 recognize and bind to NY-ESO-1-overexpressing tumor cells. This may result in a specific cytotoxic T-lymphocyte (CTL)-mediated killing of NY-ESO-1-positive tumor cells. NY-ESO-1, a tumor-associated antigen (TAA), is found in normal testis and on the surface of various tumor cell types, and is not, or is minimally, expressed in normal, healthy cells.