Definition

An off-the-shelf (OTS) preparation of allogeneic variable delta 1 (Vd1) gamma-delta (gd) T-lymphocytes, with potential immunomodulating and antineoplastic activities. Upon administration of the allogeneic Vd1 gd T-lymphocytes GDX012, these cells secrete interferon-gamma (IFN-g) and exert direct killing of tumor cells. In addition, these cells activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against tumor cells. Gamma delta T-lymphocytes play a key role in the activation of the immune system and do not require major histocompatibility complex (MHC)-mediated antigen presentation to exert their cytotoxic effect. Vd1 gd T-cells, a subset of gamma delta T-cells, recognize and are activated by cancer cells, and may therefore have a stronger association with antitumor immune responses compared with other gamma delta T-cell subtypes.