At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of Adoptive Invariant Nature Killer T Cell Therapy for Relapsed/Advanced Hepatocellular Carcinoma (HCC)
In Brief
A Phase 1 clinical trial evaluating iNKT cells, IL-2, and 1 other intervention for Hepatocellular Carcinoma. Completed, enrolled 10 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
The patients received different doses of in vitro-expanded autologous iNKT cells through intravenous infusion. The dosage was escalated from 3x10\^7 cells/m2 to 6x10\^7 cells/m2 to 9x10\^7 cells/m2. The maximum tolerated dose (MTD) was defined as the last dose level, and the dosage would be up to 1x10\^10 cells/m2 if no MTD was observed after a 3+3 design.
IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.