Full TitleA Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T cells in HLA-A2+ Patients with Synovial Sarcoma (Version date 28-MAR-2017)
The purpose of this study is to assess the safety and preliminary effectiveness of an investigational treatment in which a patient’s immune cells are altered in a laboratory and given back to the patient with the hope of provoking an immune response against synovial sarcoma.
NY-ESO-1 is a protein found on many synovial sarcomas. In this study, some of a patient’s T cells (a type of white blood cell) will be removed and modified with a gene that makes them recognize sarcoma cells containing NY-ESO-1. This approach is called “T-cell receptor gene therapy.”
Patients will first have chemotherapy with cyclophosphamide and fludarabine. They will then receive the NY-ESO-1-modified T cells. Researchers will determine if this therapy is safe and see if the altered T cells can kill synovial sarcoma cells.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have synovial sarcoma that has returned or continued to grow despite prior therapy that included ifosfamide and/or doxorubicin.
- Patients’ tumors must contain the NY-ESO-1 protein.
- Patients must be positive for HLA-A2.
- At least 3 weeks must have passed since the completion of prior therapy (1 week for biologic agents and small molecules) and entry into the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is open to patients age 4 and older.