Definition

A preparation of autologous human T-lymphocytes transduced with a lentiviral vector encoding an affinity-enhanced T-cell receptor (TCR) specific for the human leukocyte antigen (HLA)-A2-restricted peptide human melanoma antigen A4 (MAGE-A4) C1032, with potential immunostimulatory and antineoplastic activities. Upon leukapheresis, isolation, transduction, expansion ex vivo, and reintroduction into the patient, afamitresgene autoleucel targets and binds to tumor cells expressing MAGE-A4. This results in cell death of MAGE-A4-expressing tumor cells. The tumor-associated antigen (TAA) MAGE-A4, a member of the MAGE-A family of cancer testis antigens, is overexpressed by a variety of cancer cell types.