Actively Recruiting
SPEARHEAD-3 Pediatric Study
Led by USWM CT, LLC · Updated on 2026-02-09
20
Participants Needed
10
Research Sites
778 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SPEARHEAD-3 Pediatric Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of synovial sarcoma, malignant peripheral nerve sheath tumor, neuroblastoma, or osteosarcoma
- Age 2 to 17 years for synovial sarcoma; 2 to 21 years for other cancers
- Body weight of at least 10 kg
- Previous treatment with systemic chemotherapy
- Measurable disease before lymphodepletion per RECIST v1.1 or INCR criteria for neuroblastoma
- Positive for HLA-A*02
- Tumor shows MAGE-A4 expression confirmed by central lab
- Performance status: ECOG 0 or 1 for subjects 16 years or older; Lansky score 80 or higher for subjects 2 to 16 years
- Anticipated life expectancy greater than 3 months as judged by investigator
You will not qualify if you...
- Positive for HLA-A*02:05 allele or any allele with the same protein sequence
- History of allergic reactions to compounds similar to fludarabine or cyclophosphamide
- History of autoimmune or immune-mediated disease
- Known central nervous system metastases
- Previous malignancy not in complete remission
- Significant cardiovascular disease
- Active infection with HIV, hepatitis B or C, or human T cell leukemia virus
- Pregnant or breastfeeding
- Rapid disease progression increasing treatment risk as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
2
National Institutes of Health
Bethesda, Maryland, United States, 20892
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 10065
Not Yet Recruiting
4
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Memorial Sloan Kettering Kids
New York, New York, United States, 10065
Not Yet Recruiting
6
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Not Yet Recruiting
7
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
Children's Hospital of Philedephia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
10
University of Wisconsin Cancer Center
Madison, Wisconsin, United States, 53715
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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