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OncoMatch/Clinical Trials/NCT05642455

SPEARHEAD-3 Pediatric Study

Is NCT05642455 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies non-drug interventions for synovial sarcoma.

Phase 1/2RecruitingUSWM CT, LLCNCT05642455Data as of Jun 2026

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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Neuroblastoma

Osteosarcoma

Biomarker criteria

Required: HLA-A A*02 positive

HLA-A*02 positive

Required: MAGEA4 expression

Tumor shows MAGE-A4 expression confirmed by central laboratory.

Excluded: HLA-A A*02:05 positive

Positive for HLA-A*02:05 in either allele; or any A*02 having same protein sequence as HLA-A*02:05

Demographics

Ages 2–21

Prior therapy

Min 1 prior line

Must have received: systemic chemotherapy

Must have previously received a systemic chemotherapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • National Institutes of Health · Bethesda, Maryland
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • Washington University · St Louis, Missouri
  • Memorial Sloan Kettering Kids · New York, New York
  • Duke University School of Medicine · Durham, North Carolina

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05642455 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received systemic chemotherapy.

Does this trial require HLA-A?

Yes, HLA-A A*02 positive is a required biomarker for enrollment.

Does this trial require MAGEA4?

Yes, MAGEA4 expression is a required biomarker for enrollment.

Are patients with HLA-A alterations eligible?

No. HLA-A A*02:05 positive is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 21 years or younger and at least 2 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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