SPEARHEAD-3 Pediatric Study

Last updated: June 18, 2025
Sponsor: Adaptimmune
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuroblastoma

Osteosarcoma

Sarcoma (Pediatric)

Treatment

Afamitresgene autoleucel

Clinical Study ID

NCT05642455
ADP-0044-004
  • Ages 2-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, 2017Neuroblastoma 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

Exclusion Criteria:

  • Positive for HLA-A02:05 in either allele; or any A02 having same protein sequenceas HLA-A*02:05

  • History of allergic reactions attributed to compounds of similar chemical orbiologic 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 completeremission

  • Clinically significant cardiovascular disease

  • Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis Cvirus, or human T cell leukemia virus

  • Pregnant or breastfeeding

  • Experiencing ongoing rapid disease progression that in the opinion of theInvestigator significantly increases the subjects risk associated with treatment.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Afamitresgene autoleucel
Phase: 1/2
Study Start date:
September 01, 2023
Estimated Completion Date:
July 30, 2038

Connect with a study center

  • Stanford University

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045,
    United States

    Site Not Available

  • National Institue of Health

    Bethesda, Maryland 80292
    United States

    Site Not Available

  • National Institutes of Health

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 10065
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Kids

    New York, New York 10065
    United States

    Site Not Available

  • Duke University School of Medicine

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Children's Hospital of Philedephia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • University of Wisconsin Cancer Center

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

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