At a glance
ClinicalIndex Comparison Record- ✓Synovial sarcoma with prior treatment with ifosfamide and/or doxorubicin that is unresectable, metastatic, progressive/persistent, or recurrent
- ✓Measurable disease
- ✓NY-ESO-1 positive tumor (expression varies by cohort, ranging from ≥1+ in ≥1% of cells to 2+/3+ in ≥50% of cells)
- ✓HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by high resolution testing
- ✕Active HIV, HBV, HCV, or HTLV 1/2 infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
In Brief
A Phase 1 clinical trial evaluating NY-ESO-1(c259)T Cells, Fludarabine, and 1 other intervention for Neoplasms. Completed, enrolled 50 participants across 8 sites.
Detailed Summary
The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.
Study Details
Timeline
Interventions
Lymphodepleting chemotherapy followed by infusion with NY-ESO-1(c259) transduced autologous T cells. Subjects will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0.
Fludarabine will be used as lymphodepleting chemotherapy.
Cyclophosphamide will be used as lymphodepleting chemotherapy.