Phase
Condition
Neuroblastoma
Osteosarcoma
Sarcoma (Pediatric)
Treatment
Afamitresgene autoleucel
Clinical Study ID
Ages 2-21 All Genders
Study Summary
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
Connect with a study center
Stanford University
Palo Alto, California 94305
United StatesActive - Recruiting
University of Colorado
Aurora, Colorado 80045,
United StatesSite Not Available
National Institue of Health
Bethesda, Maryland 80292
United StatesSite Not Available
National Institutes of Health
Bethesda, Maryland 20892
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 10065
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Memorial Sloan Kettering Kids
New York, New York 10065
United StatesSite Not Available
Duke University School of Medicine
Durham, North Carolina 27710
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Children's Hospital of Philedephia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
University of Wisconsin Cancer Center
Madison, Wisconsin 53715
United StatesActive - Recruiting

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