Tecelra: FDA-Approved Engineered T-Cell Therapy Targeting MAGE-A4 forAdvanced Synovial Sarcoma
Trial ID: NCT04044768
Phase: Approved
Status: Completed, Available Treatment
Last Verified: June 2026
Eligibility: Adults and pediatric patients aged 12 and older with unresectable or metastatic synovial sarcoma who previously received chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and whose tumor expresses the MAGE-A4 antigen as confirmed by an FDA-approved companion diagnostic test.
Overview: Tecelra (afamitresgene autoleucel) is the first and only FDA-approved engineered T-cell therapy for a solid tumor, and the first new treatment option for synovial sarcoma in over a decade. A patient’s own white blood cells are collected, genetically engineered to recognize and attack MAGE-A4-expressing synovial sarcoma cells, and infused back in a single one-time treatment. The process, from cell collection to infusion, takes approximately six weeks and is only available at specially trained Authorized Treatment Centers (ATCs).
Preliminary Effectiveness: Based on the SPEARHEAD-1 study of 137 patients, Tecelra showed an overall response rate of 43.8%, with nearly 32% of responding patients maintaining their response for 24 months or longer.
Treatment Centers:
United States
- Memorial Sloan Kettering Cancer Center, New York, NY
- MD Anderson Cancer Center, Houston, TX
- Moffitt Cancer Center, Tampa, FL
- Mayo Clinic, Rochester, MN
- Stanford Health Care, Stanford, CA
- City of Hope, Duarte, CA
- Northwestern Memorial Hospital, Chicago, IL
- Dana-Farber Cancer Institute, Boston, MA
- Massachusetts General Hospital, Boston, MA
- Cleveland Clinic, Cleveland, OH
- Vanderbilt-Ingram Cancer Center, Nashville, TN
Note: Authorized Treatment Centers are regularly updated. Find the most current list at the TECELRA Treatment Center Finder or call AdaptimmuneAssist at 1-855-246-9232.