Definition

A preparation of autologous T lymphocytes that are engineered to express a T-cell receptor (TCR) specific for melanoma-associated antigen A1 (MAGE-A1) presented on human leukocyte antigen (HLA)-A*02:01, with potential immunomodulating and antineoplastic activities. Upon administration, the autologous anti-MAGE-A1 TCR-engineered T cells TSC-204-A0201 specifically recognize and bind to MAGE-A1 expressed on tumor cells. This may lead to cytotoxic T-lymphocyte (CTL)-mediated elimination of tumor cells expressing MAGE-A1. MAGE-A1 is a tumor-associated antigen (TAA) overexpressed by a variety of cancer cell types.