drugset / Trial / NCT05962450

Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy

NCT05962450

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to explore the efficacy and safety of autologous iNKT cells in patients with progressed hepatocellular carcinoma (HCC) after treatment with PD-1 antibody. The main question it aims to answer are: * the efficacy of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody. * the safety of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody. Participants will be randomized 1:1 to receive Regorafenib + PD-1 + iNKT cells (RPI group) or the treatment of Regorafenib + PD-1 (RP group). Researchers will compare RPI group and RP group to see whether the iNKT cells can achieve a better therapeutic effect on HCC patients with PD-1 resistance.

Timeline

Start
2023-10-26
Primary completion
2025-08-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject iNKT cells Cell therapy 108 cells Intravenous
Subject iNKT cells Cell therapy 109 cells Intravenous
Background Regorafenib Small molecule Oral