A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma
- Patients will undergo apheresis at the enrolling institution. Fresh PBMC will be
shipped to University of Pennsylvania and shipped back to the enrolling institution.
- Patients will undergo lymphodepletion with denileukin diftitox, fludarabine and
cyclophosphamide, then infusion of NY-ESO-1 genetically engineered T cells on Day 0.
- Patients will be monitored for toxicity, antitumor effects and immune endpoints.
- Patients with a PR or SD may receive a 2nd cycle no earlier than 60 days following
completion of the first cycle if eligibility criteria are met. For patients with
progressive disease, a 2nd cycle that includes high dose aldesleukin administered
beginning on the day of T cell infusion may be administered no earlier than 60 days
following completion of the first cycle if eligibility criteria are met.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the response rate.
Disease Staging Evaluation: CT scan chest, head, abdomen, pelvis. MRI of tumro, FDG-PET, Bone Scan if indicated.
Day 28, 60, 100, 180; Month 9, 12, then q6 months x 3 yrs
Crystal Mackall, MD
National Institutes of Health (NIH)
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|NIH||Bethesda, Maryland 20892|