drugset / Trial / NCT03175679
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses special immune system cells called iNKT cells, a new experimental treatment. The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).
Timeline
- Start
- 2017-04-01
- Primary completion
- 2018-12-30
- Completion
- 2019-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iNKT cells | Cell therapy | 3e+07 cells | Intravenous |
| Subject | iNKT cells | Cell therapy | 6e+07 cells | Intravenous |
| Subject | iNKT cells | Cell therapy | 9e+07 cells | Intravenous |
| Subject | iNKT cells | Cell therapy | 1e+10 cells | Intravenous |
| Background | S-1 | Small molecule | 40 mg | — |
| Background | S-1 | Small molecule | 60 mg | — |
| Background | aldesleukin | Protein / enzyme biologic | 25000 iu/kg | — |