Definition

A preparation of autologous T lymphocytes that have been genetically modified to express a T-cell receptor (TCR) specific for the human leukocyte antigen (HLA)-A*02:01-restricted TP53 (p53) R175H mutant, with potential antineoplastic activity. Upon isolation, transduction, expansion ex vivo and re-introduction into the patient, the autologous TP53 R175H mutant-specific HLA-A*02:01-restricted TCR gene engineered T lymphocytes NT-175 target and bind to tumor cells expressing the TP53 R175H mutant. This may lead to cytotoxic T-lymphocyte (CTL)-mediated elimination of tumor cells expressing the TP53 R175H mutant. p53, a tumor suppressor gene, is mutated in many tumor cells, resulting in the loss of apoptosis regulation and abnormal cell proliferation.