Definition

A preparation of autologous T lymphocytes that are genetically modified with a lentiviral vector encoding a T-cell receptor (TCR) specific for the tumor-associated antigen (TAA) preferentially expressed antigen in melanoma (PRAME) and a CD8alphabeta (CD8ab) co-receptor, with potential immunostimulating and antineoplastic activities. Upon administration back into the patient, the autologous anti-PRAME TCR/CD8ab-expressing T cells IMA203CD8 specifically recognize and bind to PRAME expressed on cancer cells, which induces a cytotoxic T-lymphocyte (CTL)-mediated immune response against the PRAME-expressing cancer cells. PRAME is overexpressed by a variety of cancer cell types. Co-expression of the CD8ab heterodimer may enhance anti-tumor immune response by engaging CD4+ T cells.