Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC
Summary
Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients receive a diagnosis when their tumors are too advanced for curative approaches and have a dismal prognosis. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but their function is defective in liver cancer. After expansion and restored function in vitro, iNKT cells can home to liver, then they play key antitumor function. We have finished a phase I study of adoptive transfer of autologous iNKT cells for treating patients with unresectable HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study was to verify the effectiveness of iNKT cell infusion in patients with unresectable HCC who had previously failed transcatheter arterial embolization (TAE) / transcatheter arterial chemoembolization (TACE).
Timeline
- Start
- 2018-03-01
- Primary completion
- 2020-03-01
- Completion
- 2023-10-01
Outcome
Met primary endpoint
paper Median PFS was significantly higher in TAE-iNKT patients (5.7 months [95% CI, 4.3-7.0 months]) compared with TAE patients PMID 37637501 ↗
registry analysis (other test); TAE/TACE+iNKT for Unresectable HCC vs TAE/TACE for Unresectable HCC; p <0.001; Hazard Ratio (HR) 0.32 (95% CI 0.16 to 0.63); Log Rank NCT04011033 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iNKT cells | Cell therapy | 5e+08 cells | — |
| Subject | iNKT cells | Cell therapy | 1e+09 cells | — |
| Background | aldesleukin | Protein / enzyme biologic | 25000 iu/kg | — |