Genetically Modified T Cells Against Ovarian Cancer
Trial Parameters
Brief Summary
The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).
Eligibility Criteria
Inclusion Criteria: 1. Written, informed consent obtained prior to any study-specific procedures. 2. Female patients ≥ 20 years. 3. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV. * Complete remission after salvage treatment for first recurrence. 7. Not pregnant, and on appropriate birth control if of childbearing potential. 8. Adequate bone marrow reserve with ·absolute neutrophil count (ANC) ≥ 1000/mm3. ·Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with ·Serum creatinine ≤ 2 x upper limit of normal (ULN). ·Serum bilirubin ≤ 2 x ULN. * aspartate aminotransferase (AST)/ALT ≤ 2 x ULN. * Alkaline phosphatase ≤ 5 x ULN. * Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome. Exclusion Criteria: 1.Patients with: * Non-epithelial ovarian cancer