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NCT05642455PHASE1, PHASE2Recruiting

SPEARHEAD-3 Pediatric Study

USWM CT, LLC

Start Date

9/1/2023

Completion Date

7/30/2038

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

Age Range: 2 years to 21 years

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.

Interventions

GENETIC

Afamitresgene autoleucel

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Conditions

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

Locations

Stanford University

Palo Alto, California 94305

United States

National Institutes of Health

Bethesda, Maryland 20892

United States

Dana Farber Cancer Institute

Boston, Massachusetts 10065

United States

Washington University

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Kids

New York, New York 10065

United States

Duke University School of Medicine

Durham, North Carolina 27710

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Children's Hospital of Philedephia

Philadelphia, Pennsylvania 19104

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

University of Wisconsin Cancer Center

Madison, Wisconsin 53715

United States