drugset / Trial / NCT04011033

Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC

NCT04011033

RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject iNKT cells Cell therapy 5e+08 cells
Subject iNKT cells Cell therapy 1e+09 cells
Background aldesleukin Protein / enzyme biologic 25000 iu/kg