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

NCT03983967 | Completed Phase 1

• 1 other identifier: ILC-IIT-07
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose (MTD) or maximum feasible dose (MFD)

  The observation of maximum tolerated dose (MTD) or maximum feasible dose (MFD) evaluation(1X10\^7cell, 5X10\^7cell, 10X10\^7cells) of immuncell-LC on hepatocellular carcinoma patients who undergo liver transplantation

  Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Secondary Outcomes (3)

• Time to Recurrence

  Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

• Recurrence-Free Survival

  Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

• Overall Survival

  Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

Study Arms (1)

Immuncell-LC group

EXPERIMENTAL

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)

Biological: Immuncell-LC

Interventions

Immuncell-LC BIOLOGICAL

Activated T lymphocyte

Immuncell-LC group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (1)

Seoul National Hospital

Seoul, 110-744, South Korea

Location

Study Officials

• Kyung Suk Suh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: June 12, 2019
• Study Start: January 24, 2019
• Primary Completion: September 9, 2021
• Study Completion: August 30, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)