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ACTIVE NOT RECRUITING
NCT04044768
PHASE2

Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Sponsor: USWM CT, LLC

View on ClinicalTrials.gov

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

Interventions

GENETIC

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