Taking people in United StatesPhase 1/2
Tests afamitresgene autoleucel in children with MAGE-A4 positive advanced cancers
Tests a cell therapy in children with certain advanced tumors that carry MAGE-A4.
Key facts
- Who runs it
- USWM CT, LLC
- Where
- Bethesda, Boston, Cincinnati, Durham, Madison, New York, Palo Alto, Philadelphia, Seattle, and St Louis, United StatesSee the 10 sites
- Trial code
- Registry title
- SPEARHEAD-3 Pediatric Study
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 20 people, planned
- Started
- 1 Sept 2023
- Expected to end
- 30 Jul 2038
- Type of study
- Interventional
- Treatments tested
- Afamitresgene autoleucel
- Record updated
- 11 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young people with synovial sarcoma, MPNST, neuroblastoma or osteosarcoma. The tumor must show MAGE-A4, and the person must be HLA-A*02 positive.
- Age
- Synovial sarcoma: 2 to 17 years. MPNST, neuroblastoma and osteosarcoma: 2 to 21 years.
- Sex
- All sexes can join.
- Disease stage
- Cancer confirmed under the microscope as synovial sarcoma, MPNST, neuroblastoma or osteosarcoma. The disease must be measurable. Life expectancy must be more than 3 months in the investigator's opinion.
- Earlier treatment
- Must have already had systemic chemotherapy.
- Biomarker or test result
- HLA-A*02 positive. The tumor must show MAGE-A4, confirmed by a central laboratory. Body weight of at least 10 kg (22 lb).
Main reasons for not taking part
- HLA-A*02:05 in either allele
- History of autoimmune or immune mediated disease
- Known cancer spread to the central nervous system (CNS)
- Active infection with HIV, hepatitis B, hepatitis C or human T cell leukemia virus
- Pregnant or breastfeeding
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in United States
- National Institutes of HealthBethesda, United StatesContact: Jessica LakeTaking people
- Dana-Farber Cancer InstituteBoston, United StatesContact: Alyssa GiammancoTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Brian Turpin, DOTaking people
- Duke University School of MedicineDurham, United StatesContact: Kris Mahadeo, MDTaking people
- University of Wisconsin Cancer CenterMadison, United StatesContact: Jenny Weiland, BSTaking people
- Memorial Sloan Kettering KidsNew York, United StatesContact: Fiorella Iglesias Cardenas, MDTaking people
- Stanford UniversityPalo Alto, United StatesContact: Amy LiTaking people
- Children's Hospital of PhiledephiaPhiladelphia, United StatesContact: Shelby Brizzolara-Dove, BSTaking people
- Seattle Children's HospitalSeattle, United StatesContact: CBDC IntakeTaking people
- Washington UniversitySt Louis, United StatesContact: Tina Primeau, BATaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Afamitresgene autoleucelTreatment being tested
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests afamitresgene autoleucel in children with MAGE-A4 positive advanced cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05642455, who can take part
- Record updated
- 11 August 2026