drugset / Trial / NCT05962450
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
Phase 2
Unknown
84 enrolled
Beijing YouAn Hospital
Beijing Gene Key Life Technology Co., Ltd · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iNKT cells | Cell therapy | 108 cells | Intravenous |
| Subject | iNKT cells | Cell therapy | 109 cells | Intravenous |
| Background | Regorafenib | Small molecule | — | Oral |