drugset / Trial / NCT03093688
Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-03-01
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
Publications
- Wang J, Cheng X, Jin Y, Xia B, Qin R, Zhang W, Hu H, Mao X, Zhou L, Yan J, Zhang X, Xu J. Safety and Clinical Response to Combined Immunotherapy with Autologous iNKT Cells and PD-1+CD8+ T Cells in Patients Failing First-line Chemotherapy in Stage IV Pancreatic Cancer. Cancer Res Commun. 2023 Jun 7;3(6):991-1003. doi: 10.1158/2767-9764.CRC-23-0137. eCollection 2023 Jun.
- Cheng X, Wang J, Qiu C, Jin Y, Xia B, Qin R, Hu H, Yan J, Zhang X, Xu J. Feasibility of iNKT cell and PD-1+CD8+ T cell-based immunotherapy in patients with lung adenocarcinoma: Preliminary results of a phase I/II clinical trial. Clin Immunol. 2022 May;238:108992. doi: 10.1016/j.clim.2022.108992. Epub 2022 Mar 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD8+T cells | Unknown | 1e+07 cells | — |
| Subject | CD8+T cells | Unknown | 1e+09 cells | — |
| Subject | iNKT cells | Cell therapy | 1e+08 cells | — |
| Subject | iNKT cells | Cell therapy | 1e+10 cells | — |