Definition

An off-the-shelf (OTS) preparation of human allogeneic T lymphocytes obtained from healthy donors that are engineered to express a chimeric antigen receptor (CAR) specific for the tumor-associated antigen (TAA) human cluster of differentiation 70 (CD70) and gene-edited with transcription activator-like effector nuclease (TALEN) to inactivate the endogenous T-cell receptor alpha constant (TRAC) and CD52 loci, with potential immunostimulating and antineoplastic activities. Upon introduction into the patient, the allogeneic anti-CD70-CAR T cells ALLO-316 recognize and bind to CD70-expressing tumor cells. This may result in a specific cytotoxic T-lymphocyte (CTL)-mediated killing of CD70-positive tumor cells. CD70, a type II transmembrane glycoprotein and member of the tumor necrosis factor (TNF) family, is found on the surfaces of various types of cancer cells. Deletion of the CD52 gene makes the modified donor T cells resistant to anti-CD52 monoclonal antibodies, which can be used during lymphodepletion. The deletion of the TRAC gene abrogates the potential induction of graft-versus-host disease (GvHD) by the donor T cells.