SPEARHEAD-3 Pediatric Study: Afamitresgene Autoleucel (Tecelra) inChildren and Young Adults With Advanced Synovial Sarcoma
Trial ID: NCT05642455
Phase: Phase 1/2
Status: Recruiting
Last Update Posted: February 2026
Eligibility: Children and young adults aged 2 to 17 with synovial sarcoma who are HLA-A*02 positive, whose tumors express MAGE-A4 confirmed by central laboratory, weigh at least 10 kg, have received prior systemic chemotherapy, and have measurable disease. Good performance status is required (ECOG 0-1 for patients aged 16 and older; Lansky score ≥80 for those under 16).
Overview: This Phase 1/2 pediatric basket study expands the evaluation of afamitresgene autoleucel (afami-cel, Tecelra) to pediatric patients with synovial sarcoma, malignant peripheral nerve sheath tumor, neuroblastoma, and osteosarcoma. As in adult treatment, a patient’s own T-cells are collected, genetically modified to recognize MAGE-A4-expressing cancer cells, and infused back after lymphodepleting chemotherapy. Results for each cancer type are tracked separately. Phase 1 evaluates safety and dose; Phase 2 evaluates anti-tumor activity in the pediatric population.
Preliminary Effectiveness: In adult clinical trials, afami-cel achieved a 39% response rate in advanced synovial sarcoma, leading to its FDA approval. Pediatric data is still emerging. This study aims to determine whether similar efficacy extends to younger patients, with early case reports showing promise.
Treatment Centers: USA
- Stanford University, Palo Alto, CA
- National Institutes of Health, Bethesda, MD
- Dana-Farber Cancer Institute, Boston, MA
- Washington University, St. Louis, MO
- Memorial Sloan Kettering Kids, New York, NY
- Duke University School of Medicine, Durham, NC
- Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
- Children’s Hospital of Philadelphia, Philadelphia, PA
- Seattle Children’s Hospital, Seattle, WA
- University of Wisconsin Cancer Center, Madison, WI