Spearhead 1 Study for Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Sponsor: Adaptimmune
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
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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.
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