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Recruiting Phase 1/2

SPEARHEAD-3 Pediatric Study

NCT05642455 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2023-09-01
Last updated
2026-08-11

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Afamitresgene autoleucel

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

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

Sex
ALL
Min age
2 Years
Max age
21 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation. — 3.5 years
    Determination of incidence, severity and duration of adverse events * Incidence of dose limiting toxicities DLTs * AEs including serious adverse events (SAEs) * Incidence, severity, and duration of the AEs of special interest * Replication competent lentivirus (RCL) * T-cell clonality and insertional oncogenesis (IO)

Trial sites (10)

FacilityCityRegionStatus
Stanford University Palo Alto California Recruiting
National Institutes of Health Bethesda Maryland Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Washington University St Louis Missouri Recruiting
Memorial Sloan Kettering Kids New York New York Recruiting
Duke University School of Medicine Durham North Carolina Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
Children's Hospital of Philedephia Philadelphia Pennsylvania Recruiting
Seattle Children's Hospital Seattle Washington Recruiting
University of Wisconsin Cancer Center Madison Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05642455 on ClinicalTrials.gov ↗ ← All trials in the USA