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Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC

NCT03175679 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-19

Study results available
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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).

Conditions

Interventions

BIOLOGICAL

iNKT cells

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.

DRUG

IL-2

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

DRUG

Tegafur

Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

Sponsors & Collaborators

  • Beijing YouAn Hospital

    lead OTHER

Principal Investigators

  • Jun Lu, Director · Beijing YouAn Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-12-30
Completion
2019-03-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03175679 on ClinicalTrials.gov