A Phase I/IIA Study Evaluating the Safety and Efficacy of NY-ESO-1TCR/dnTGFBRII Engineered T Cells in Combination With Decitabine in Subjects With Recurrent or Treatment Refractory Ovarian Cancer and Other Advanced Malignancies
University of Chicago
Summary
This phase I/IIA trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult subjects (18 years and older) with histologically or cytologically of advanced (metastatic or inoperable) advanced solid tumors. * Tumor (either an archival specimen or a fresh biopsy) shows NY-ESO-1 expression of 1+ by IHC (H-score). NY-ESO-1 expression must be confirmed by central validated assay. * Patients with NY-ESO-1 expressing solid tumors will be included. Patients must have received, been intolerant of, or been ineligible to receive at least 2 lines of the current standard of care therapy including but not limited to chemotherapy, immunotherapy and/or tar…
Interventions
- DrugDecitabine
Decitabine taken by mouth 15 mg/m2/day x 5 days, IV; Days -10 to -6
- DrugCyclophosphamide Conditioning
Cyclophosphamide Conditioning will be 45 mg/kg x 2 days IV; Days -4 \& -3
- BiologicalNY-ESO-1 TCR/ dnTGFβRII
The dose of NY-ESO-1 TCR/ dnTGFβRII to be tested will vary depending on assigned arm.
- DrugAldesleukin
Aldesleukin taken by mouth500,000 IU/m2 SC BID; Days +1 to +10
Location
- University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois