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
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