Definition

Human autologous T lymphocytes transduced with a retroviral vector encoding a human leukocyte antigen (HLA)-A*02:01-restricted T-cell receptor (TCR) specific for the human tumor-associated antigen (TAA) preferentially expressed antigen in melanoma (PRAME) coupled to the CD3 signaling complex, with potential antineoplastic activity. Upon reintroduction into the patient, the autologous PRAME-targeting TCR-modified T cells MDG1011 target and bind to tumor cells expressing PRAME. This may induce cell death in and halt the growth of PRAME-expressing tumor cells. The TAA PRAME is overexpressed by a variety of cancer cell types.