SPL Set ID: ab24631f-3364-46e1-8074-7244863bcbab

TECELRA (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE- A4)-directed genetically modified autologous T cell immunotherapy product consisting of CD4 and CD8 positive T cells transduced with a self-inactivating lentiviral vector (LV) expressing an affinity-enhanced T cell receptor (TCR) specific for the human MAGE-A4. Autologous T cells transduced with MAGE-A4-c1032 LV express the affinity-enhanced TCR on the cell surface. The TCR recognizes an HLA-A*02 restricted MAGE-A4 peptide. MAGE-A4 is an intracellular cancer-testis antigen that has restricted expression in normal tissues and is expressed in synovial sarcoma. TECELRA is prepared from the patient's peripheral blood mononuclear cells (PBMCs), which are obtained via a standard leukapheresis procedure. The PBMCs are enriched for T cells and are then transduced with a replication-incompetent LV containing the MAGE-A4 TCR transgene. The transduced T cells are expanded, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release and shipping as a frozen suspension in one or more infusion bag(s). The product is thawed prior to infusion back into the patient [see Preparation and Administration ( 2.2 ), How Supplied/Storage and Handling ( 16 )]. The drug product formulation contains 5% dimethyl sulfoxide (DMSO).