Definition

A preparation of autologous CD4- and CD8-positive T lymphocytes that have been engineered with site-specific nucleases to suppress the expression of most endogenous forms of the T-cell receptor (TCR) and promote expression of a single, native TCR targeting a neoepitope that is presented on the surface of a patient’s tumor cells, with potential immunostimulating and antineoplastic activities. Upon reintroduction into the patient, the gene-edited autologous neoantigen-targeted NeoTCR-P1 T cells recognize and bind to tumor cells expressing the targeted neoantigen, resulting in a cytotoxic T-lymphocyte (CTL)-mediated immune response against the patient’s tumor cells.