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Recruiting nowPhase 1/2Ages 2 Years to 21 Years

SPEARHEAD-3 Pediatric Study

Sponsor: USWM CT, LLC · NCT05642455 on ClinicalTrials.gov ↗

Conditions studied

Synovial SarcomaMalignant Peripheral Nerve Sheath Tumor (MPNST)Neuroblastoma (NBL)Osteosarcoma

What it tests

  • Afamitresgene autoleucelgenetic

Where it's running10 sites

  • Stanford University

    Palo Alto, California 94305

    Recruiting now
  • National Institutes of Health

    Bethesda, Maryland 20892

    Recruiting now
  • Dana Farber Cancer Institute

    Boston, Massachusetts 10065

    Opening soon
    • Natalie Collins, MD(principal investigator)
  • Washington University

    St Louis, Missouri 63110

    Recruiting now
  • Memorial Sloan Kettering Kids

    New York, New York 10065

    Opening soon
  • Duke University School of Medicine

    Durham, North Carolina 27710

    Opening soon
  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229

    Recruiting now
  • Children's Hospital of Philedephia

    Philadelphia, Pennsylvania 19104

    Recruiting now
  • Seattle Children's Hospital

    Seattle, Washington 98105

    Opening soon
    • Mark Fluchel, MD(principal investigator)
  • University of Wisconsin Cancer Center

    Madison, Wisconsin 53715

    Recruiting now
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.