afamitresgene autoleucel

Afamitresgene autoleucel is a **melanoma-associated antigen A4-directed genetically modified autologous T cell immunotherapy** developed by Adaptimmune for synovial sarcoma. It is an autologous **T cell receptor engineered T cell therapy** composed of a patient's own CD4-positive and CD8-positive T cells transduced with a lentiviral vector encoding an affinity-enhanced T cell receptor that recognizes **MAGE-A4** presented in the context of specific **HLA-A*02** alleles. Following lymphodepleting chemotherapy, it is administered as a **single intravenous infusion** to mediate antigen-specific killing of MAGE-A4-expressing tumor cells. The product received **FDA accelerated approval in August 2024** for adults with unresectable or metastatic synovial sarcoma after prior chemotherapy whose tumors express MAGE-A4 and who are positive for eligible HLA-A*02 subtypes, making it the first FDA-approved TCR gene therapy and the first approved gene therapy for synovial sarcoma.

Brand names

TECELRA

Other names

afamitresgene autoleucel