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

Last updated: January 8, 2025
Sponsor: Adaptimmune
Overall Status: Active - Not Recruiting

Phase

2

Condition

Sarcoma

Soft Tissue Sarcoma

Infantile Fibrosarcoma

Treatment

afamitresgene autoleucel (previously ADP-A2M4)

Clinical Study ID

NCT04044768
ADP 0044-002
  • Ages 10-75
  • All Genders

Study 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) .

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

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: afamitresgene autoleucel (previously ADP-A2M4)
Phase: 2
Study Start date:
August 13, 2019
Estimated Completion Date:
April 01, 2038

Connect with a study center

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Hospital Maisonneuve-Rosemont

    Montréal, QCH1T2M5
    Canada

    Site Not Available

  • Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

    Bordeaux, 33076
    France

    Site Not Available

  • Centre Leon Berard

    Lyon,
    France

    Site Not Available

  • Hospital Haut Leveque, CHU Bordeaux

    Pessac, 33604
    France

    Site Not Available

  • Gustave Roussy Cancer Center

    Villejuif, 94805
    France

    Site Not Available

  • Hospital Universitari Vall D'Hebron

    Barcelona, Cataluna 119-129
    Spain

    Site Not Available

  • Start Madrid-FJD, Fundación Jimѐnez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • UCLH Cancer Clinical Trials Unit

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Stanford Cancer Center

    Palo Alto, California 94305
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Northwestern University Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois 60611
    United States

    Site Not Available

  • National Cancer Institute

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mayo Clinic Clinical Trial Referral Office

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Vanderbilt

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Fred Hutch

    Seattle, Washington 98109
    United States

    Site Not Available

  • Medical College of WI Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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