Afamitresgene autoleucel (brand name Tecelra) is a first-in-class T-cell receptor (TCR) gene therapy approved for the treatment of adults with unresectable or metastatic synovial sarcoma.
Indication: It is specifically indicated for patients who have already received chemotherapy and meet two critical biomarker criteria:
They must be positive for specific HLA-A*02 alleles (such as HLA-A*02:01P, 02:02P, 02:03P, or 02:06P).
Their tumor must express the MAGE-A4 antigen.
Mechanism: This is an autologous immunotherapy, meaning it is made from the patient’s own white blood cells.
The T cells are genetically modified in a lab to recognize and attack cancer cells expressing the MAGE-A4 protein.
The SPEARHEAD-1 clinical trial, which showed an overall response rate of approximately 39–43%.
Administration: It is given as a single intravenous infusion following a short course of lymphodepleting chemotherapy (typically fludarabine and cyclophosphamide).
The treatment carries a Boxed Warning for Cytokine Release Syndrome (CRS), which can be severe or life-threatening.
Other potential side effects include neurotoxicity (ICANS), prolonged low blood counts (cytopenia), and severe infections.
Cost: A single dose is priced at approximately $727,000.