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Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Sponsor: USWM CT, LLC
Summary
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
Official title: A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Key Details
Gender
All
Age Range
10 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2019-08-13
Completion Date
2038-04-01
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
afamitresgene autoleucel (previously ADP-A2M4)
Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion
Locations (26)
City of Hope
Duarte, California, United States
Stanford Cancer Center
Palo Alto, California, United States
University of Colorado
Aurora, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
National Cancer Institute
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
Vanderbilt
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutch
Seattle, Washington, United States
Medical College of WI Froedtert Hospital
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Leon Berard
Lyon, France
Hospital Haut Leveque, CHU Bordeaux
Pessac, France
Gustave Roussy Cancer Center
Villejuif, France
Hospital Universitari Vall D'Hebron
Barcelona, Catalonia, Spain
Start Madrid-FJD, Fundación Jimѐnez Díaz
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
UCLH Cancer Clinical Trials Unit
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom