Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients Wi
Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of
| Condition(s) | Non-small Cell Lung Cancer, Small Cell Lung Cancer, Pancreas Cancer, Hepatocellular Carcinoma, Gastric Cancer, Renal Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing of iNKT cells and PD-1+CD8+T cells. |
| Who can participate | Inclusion Criteria: * Histological or cytologically diagnosis of advanced lung cancer, or advanced gastric cancer, or advanced pancrease cancer, or hepatocellular carcinoma, or advanced colorectal cancer * Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology * Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal * No dyspnea at rest. Oxygen saturation ≥90% on room air * No genetic disease * Fertile females/males m |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Shanghai Public Health Clinical Center |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2017-03-01 |
| NCT ID | NCT03093688 |
| Official listing | https://clinicaltrials.gov/study/NCT03093688 |