MedTrace Logo

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

NCT05962450 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-01-16

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

iNKT Cells

the iNKT cells will be intravenous infused every two weeks as a course of treatment for up to six courses , the reinfusion dose is determined according to the patient's body surface area, which was about 108\~109cells/m2.

DRUG

PD-1

Intravenous infusion, according to the drug instructions.

DRUG

Regorafenib

Oral administration, according to the drug instructions.

Sponsors & Collaborators

  • Beijing Gene Key Life Technology Co., Ltd

    collaborator INDUSTRY

  • Beijing YouAn Hospital

    lead OTHER

Principal Investigators

  • Jun Lu, MD. · Beijing YouAn Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT05962450 on ClinicalTrials.gov