SPEARHEAD-3 Pediatric Study
Sponsor: USWM CT, LLC · NCT05642455 on ClinicalTrials.gov ↗
Conditions studied
What it tests
- Afamitresgene autoleucelgenetic
Where it's running10 sites
- Recruiting now
Stanford University
Palo Alto, California 94305
- Amy Li(contact)650-788-6811[email protected]
- Sneha Ramakrishna, MD(principal investigator)
- Recruiting now
National Institutes of Health
Bethesda, Maryland 20892
- Kane Kaosaard(contact)301-204-9057[email protected]
- John Glod, MD(principal investigator)
- Opening soon
Dana Farber Cancer Institute
Boston, Massachusetts 10065
- Natalie Collins, MD(principal investigator)
- Recruiting now
Washington University
St Louis, Missouri 63110
- Tina Primeau, BA(contact)314-454-2147[email protected]
- Catie Knoerle, BA(contact)314-747-1828[email protected]
- Amy Armstrong, MD(principal investigator)
- Opening soon
Memorial Sloan Kettering Kids
New York, New York 10065
- Fiorella Iglesias Cardenas, MD(contact)212-639-6649[email protected]
- Fiorella Iglesias Cardenas, MD(principal investigator)
- Opening soon
Duke University School of Medicine
Durham, North Carolina 27710
- Kris Mahadeo, MD(contact)919-668-1180[email protected]
- Kris Mahadeo, MD(principal investigator)
- Recruiting now
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
- Brian Turpin, DO(contact)513-636-2799[email protected]
- Brian Turpin, DO(principal investigator)
- Recruiting now
Children's Hospital of Philedephia
Philadelphia, Pennsylvania 19104
- Shelby Brizzolara-Dove, BS(contact)267-425-5544[email protected]
- Theodore Laetsch, MD(principal investigator)
- Opening soon
Seattle Children's Hospital
Seattle, Washington 98105
- Mark Fluchel, MD(principal investigator)
- Recruiting now
University of Wisconsin Cancer Center
Madison, Wisconsin 53715
- Jenny Weiland, BS(contact)608-890-8070[email protected]
- Christian Capitini, MD(principal investigator)
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
Inclusion Criteria: * 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 Criteria: * Positive for HLA-A\*02:05 in either allele; or any A\*02 having same protein sequence as HLA-A\*02:05 * History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide. * History of autoimmune or immune mediated disease * Known central nervous system (CNS) metastases. * 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 * Pregnant or breastfeeding * Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.
Updated 2026-02-09 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.