SPEARHEAD-3 Pediatric Study
Key facts
- Where
- Bethesda, Boston, Cincinnati, Durham, Madison, New York, Palo Alto, Philadelphia, Seattle, and St Louis, United StatesSee the 10 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 21 years old?
Source: NCT05642455, who can take part
Where in United States
- National Institutes of HealthBethesda, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- Duke University School of MedicineDurham, United StatesTaking people
- University of Wisconsin Cancer CenterMadison, United StatesTaking people
- Memorial Sloan Kettering KidsNew York, United StatesTaking people
- Stanford UniversityPalo Alto, United StatesTaking people
- Children's Hospital of PhiledephiaPhiladelphia, United StatesTaking people
- Seattle Children's HospitalSeattle, United StatesTaking people
- Washington UniversitySt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- USWM CT, LLC
- Trial code
- NCT05642455
- Record updated
- 11 August 2026
- Original description
This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.Read full original descriptionShow less
A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors
This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.
Inclusion: Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS); Age:; (A) Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years; Body weight ≥ 10 kg; Must have previously received a systemic chemotherapy; Measurable disease prior to lymphodepletion according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only); HLA-A*02 positive; Tumor shows MAGE-A4 expression confirmed by central laboratory; Performance Status:; (A) Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80; Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.
Exclusion: History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide; History of autoimmune or immune mediated disease; Other prior malignancy that is not considered by the Investigator to be in complete remission; Clinically significant cardiovascular disease; Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus; Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment; Positive for HLA-A*02:05 in either allele; or any A*02 having same protein sequence as HLA-A*02:05; Known central nervous system (CNS) metastases; Pregnant or breastfeeding.