Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation

NCT ID: NCT03983967

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2022-08-30

Brief Summary

The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation.

Detailed Description

ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated.

For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.

Conditions

Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immuncell-LC group

Adjuvant adoptive immune therapy using a CIK cell agent(Cytokine-Induced Killer cells; Immuncell-LC) 3 times(3 treatments at a frequency of once per week) or 6 times(3 treatments at a frequency of once per week followed by 3 treatments every 2 weeks)

Group Type: EXPERIMENTAL

Immuncell-LC

Intervention Type: BIOLOGICAL

Activated T lymphocyte

Interventions

Immuncell-LC

Activated T lymphocyte

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients who are more than 20 and less than 80 years old.
• Patients whose expected life expectancy is at least 16 weeks (4 months).
• Patients who receive liver transplants exceeding the Milan Criteria.
• ECOG Performance Status (ECOG-PS) score is 0-2.
• Patients who satisfy the following conditions of the blood test and kidney, liver function test.

Absolute neutrophil count > 500x10^6L Hemoglobin ≥ 7.5 g/dL Platelet count > 20,000/㎣ Total bilirubin < 15mg/㎗

•Patients who have agreed to participate in the study voluntarily by signing on informed consent form.

Exclusion Criteria

• Patients who have received in vitro radiation therapy, systemic chemotherapy within 4 weeks based on sign date of Informed consent form.
• Patients who undergo ABO incompatible Liver Transplantation.
• Patients who had previously administered cell therapy.
• Patients who are confirmed with Acquired Immune Deficiency Syndrome (AIDS).
• Patients who are currently receiving dialysis.
• Patients who participated in another clinical trial and received treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date.
• Patients who have uncontrollable or serious disease.
• Patients who are unable to use appropriate methods of contraception during the study period.
• Patient whose tumor has not been removed or liver metastasis is confirmed.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GC Cell Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung Suk Suh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ILC-IIT-07

Identifier Type: -

Identifier Source: org_study_id