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SPEARHEAD-3 Pediatric Study
Sponsor: USWM CT, LLC
Summary
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.
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
Key Details
Gender
All
Age Range
2 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-09-01
Completion Date
2038-07-30
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Afamitresgene autoleucel
Single infusion of afamitresgene autoleucel Dose: For subjects ≥10 kg to \<40 kg: starting dose of 0.025 - 0.200 x 10'9 transduced cells/kg. For subjects ≥40 kg 1.0x109 to 10x109 transduced by a single intravenous infusion
Locations (10)
Stanford University
Palo Alto, California, United States
National Institutes of Health
Bethesda, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Kids
New York, New York, United States
Duke University School of Medicine
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philedephia
Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin Cancer Center
Madison, Wisconsin, United States