SPEARHEAD-1 Study in Subjects With Advanced Synovial Sarcoma orMyxoid/Round Cell Liposarcoma
Trial ID: NCT04044768
Phase: Phase 2
Status: Active but not recruiting
Last Update Posted: February 2026
Please Note: This trial is no longer enrolling new patients but remains active for long-term follow-up of enrolled participants.
Eligibility: Patients aged 10 to 75 years with advanced synovial sarcoma who previously received an anthracycline or ifosfamide-containing chemotherapy regimen, have measurable disease, are positive for HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06, and whose tumor shows MAGE-A4 expression confirmed by central laboratory testing.
Overview: This ongoing study evaluates afamitresgene autoleucel (afami-cel), commercially known as Tecelra, a treatment using patients’ own genetically modified T-cells to target and destroy synovial sarcoma cells expressing the MAGE-A4 antigen. Patients first undergo chemotherapy to prepare the body for treatment, after which their genetically modified T-cells are infused back into their bloodstream to specifically attack the cancer cells. This continuing study aims to confirm long-term effectiveness, safety, and potential side effects in enrolled participants. Principal Investigator: Dejka Araujo, MD, MD Anderson Cancer Center.
Preliminary Effectiveness: Results published in The Lancet (April 2024) confirmed meaningful and durable tumor responses in patients with advanced synovial sarcoma who had previously received chemotherapy. Long-term follow-up is estimated to continue through April 2038, tracking overall survival and duration of response in enrolled patients.
Treatment Centers: USA, Canada, France, Spain, UK