Definition

A preparation of autologous T lymphocytes genetically modified to express a T-cell receptor (TCR) specific for an as of yet undisclosed tumor-associated antigen (TAA), with potential antineoplastic activity. Peripheral blood mononuclear cells (PBMCs) are isolated from a patient, transduced with a TCR specific for the TAA, and expanded ex-vivo. Upon reintroduction into the patient, the autologous engineered TCR-T cells KSH01 target and bind to tumor cells expressing the TAA, which may induce cell death in and halt the growth of cancer cells expressing the undisclosed TAA.