Spearhead 1 Study for Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Sponsor: Adaptimmune

Sponsor score: 60

ClinicalTrials ID:NCT04044768

This clinical trial is testing a new treatment called ADP-A2M4 for patients with advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) that cannot be removed by surgery or has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new treatment, ADP-A2M4, in patients who have advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) that cannot be surgically removed or has spread. Participants must have specific genetic markers (HLA-A*02 and MAGE-A4) to be eligible for the study.

Eligibility Criteria

Exclusion Criteria

  • Have a specific genetic marker called HLA-A*02:05.
  • Have received or plan to receive certain treatments before the study, such as:
    • Chemotherapy or tyrosine kinase inhibitors (e.g., pazopanib).
    • Immune therapies, including monoclonal antibodies or checkpoint inhibitors.
    • Anti-cancer vaccines or gene therapy using certain vectors.
    • Corticosteroids or other immunosuppressive therapies.
    • Participation in other investigational treatments or clinical trials.
    • Allogeneic stem cell transplant.
    • Radiation therapy to the target cancer areas.
    • Major surgery.
  • Have a history of allergic reactions to similar drugs used in the study.
  • Have a history of autoimmune or immune-mediated diseases.
  • Have cancer that has spread to the brain or spinal cord.
  • Have another type of cancer that is not in complete remission.
  • Have significant heart disease.
  • Have uncontrolled illnesses.
  • Have active infections with HIV, hepatitis B, hepatitis C, or human T cell leukemia virus.
  • Are pregnant or breastfeeding.

Note: Other exclusion criteria may apply as defined by the study protocol.

Locations

FACILITYZIPCITYSTATE
City of Hope91010DuarteCalifornia
Stanford Cancer Center94305Palo AltoCalifornia
University of Colorado80045AuroraColorado
Mayo Clinic Jacksonville33612JacksonvilleFlorida
Moffitt Cancer Center33612TampaFlorida
Northwestern University Robert H. Lurie Comprehensive Cancer Center60611ChicagoIllinois
National Cancer Institute20892BethesdaMaryland
Massachusetts General Hospital02114BostonMassachusetts
Dana Farber Cancer Institute02215BostonMassachusetts
University of Michigan48109Ann ArborMichigan

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