Phase
Condition
Sarcoma
Sarcoma (Pediatric)
Infantile Fibrosarcoma
Treatment
afamitresgene autoleucel (previously ADP-A2M4)
Clinical Study ID
Ages 10-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria
Age ≥16 (10 years at selected sites) and <=75 years
Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) or myxoidliposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed bycytogenetics.
Previously received either an anthracycline or ifosfamide containing regimen.
Measurable disease according to RECIST v1.1 prior to lymphodepletion
HLA-A02:01, HLA-A02:02, HLA-A02:03 or HLA-A02:06 positive
Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only (United States and Canada): Tumor (either an archival specimen or a fresh biopsy)shows MAGE-A4 expression of ≥1+ staining in ≥10% of the cells byimmunohistochemistry.
ECOG Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old:
Lansky Score ≥60%.
• Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Exclusion
Key Exclusion Criteria:
HLA-A*02:05 in either allele
Received or plans to receive the following therapy/treatment prior to leukapheresisor lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor (TKI) (e.g. pazopanib), Immune therapy (including monoclonal antibody therapy,checkpoint inhibitors,), Anti-cancer Vaccine, Gene therapy using an integratingvector (subjects who have received a gene therapy using a lentiviral vector may beeligible for the study), Corticosteroids or any other immunosuppressive therapy,Investigational treatment or interventional clinical trial, Allogeneic hematopoieticstem cell transplant, Radiotherapy to the target lesions, Major surgery
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to fludarabine, cyclophosphamide or other agents used in thestudy.
History of autoimmune or immune mediated disease
Symptomatic CNS metastases including leptomeningeal disease.
Other prior malignancy that is not considered by the Investigator to be in completeremission
Clinically significant cardiovascular disease
Uncontrolled intercurrent illness
Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis Cvirus, or human T cell leukemia virus
Pregnant or breastfeeding
Note: other protocol defined Exclusion criteria may apply.
Study Design
Connect with a study center
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Hospital Maisonneuve-Rosemont
Montréal, QCH1T2M5
CanadaSite Not Available
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
Bordeaux, 33076
FranceSite Not Available
Centre Leon Berard
Lyon,
FranceSite Not Available
Hospital Haut Leveque, CHU Bordeaux
Pessac, 33604
FranceSite Not Available
Gustave Roussy Cancer Center
Villejuif, 94805
FranceSite Not Available
Hospital Universitari Vall D'Hebron
Barcelona, Cataluna 119-129
SpainSite Not Available
Start Madrid-FJD, Fundación Jimѐnez Díaz
Madrid, 28040
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
UCLH Cancer Clinical Trials Unit
London, NW1 2PG
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester, M20 4BX
United KingdomSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Stanford Cancer Center
Palo Alto, California 94305
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville, Florida 33612
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois 60611
United StatesSite Not Available
National Cancer Institute
Bethesda, Maryland 20892
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Mayo Clinic Clinical Trial Referral Office
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Columbia University
New York, New York 10032
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Vanderbilt
Nashville, Tennessee 37212
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Fred Hutch
Seattle, Washington 98109
United StatesSite Not Available
Medical College of WI Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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