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

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ClinicalTrials.gov Identifier: NCT03983967
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation

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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Biological: Immuncell-LC Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increased Dose, Repeated Injection Clinical to Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation With Hepatocellular Carcinoma Exceeding the Milan Criteria
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : December 23, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Biological: Immuncell-LC
Activated T lymphocyte




Primary Outcome Measures :
  1. maximum tolerated dose (MTD) or maximum feasible dose (MFD) [ Time Frame: 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 ]
    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


Secondary Outcome Measures :
  1. Time to Recurrence [ Time Frame: 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 ]
    Time to Recurrence is defined as the recurring time of the cancer.

  2. Recurrence-Free Survival [ Time Frame: 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 is defined as the recurring time of the cancer or death.

  3. Overall Survival [ Time Frame: 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 is defined as the time of death from administraion of investigational product.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983967


Contacts
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Contact: Kyung Suk Suh, MD 82-2-2072-3789 kssuh@snu.ac.kr

Locations
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Korea, Republic of
Seoul National Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyung Suk Suh, MD    82-2-20723789    kssuh@snu.ac.kr   
Principal Investigator: Kyung Suk Suh, MD         
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
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Principal Investigator: Kyung Suk Suh, MD Seoul National University Hospital
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Responsible Party: Green Cross Cell Corporation
ClinicalTrials.gov Identifier: NCT03983967    
Other Study ID Numbers: ILC-IIT-07
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No