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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983967
• Other study ID #: ILC-IIT-07
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 24, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2023
• Source: GC Cell Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 30, 2022
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Biological:
• Immuncell-LC
Activated T lymphocyte

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Recurrence	Time to Recurrence is defined as the recurring time of the cancer.	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	Recurrence-Free Survival	Recurrence-Free Survival is defined as the recurring time of the cancer or death.	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	Overall Survival	Overall Survival is defined as the time of death from administraion of investigational product.	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