Liver TransplantationPhase 1/2NCT03983967
Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation
A Phase 1/2 study testing Immuncell-LC in people with Liver Transplantation, run by GC Cell Corporation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Immuncell-LC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jan 2019to 30 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Immuncell-LC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immuncell-LCBiological
Activated T lymphocyte
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Immuncell-LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Time to Recurrence is defined as the recurring time of the cancer.
Measured: 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
Recurrence-Free Survival is defined as the recurring time of the cancer or death.
Measured: 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
Overall Survival is defined as the time of death from administraion of investigational product.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start24 Jan 2019
- Primary completion9 Sep 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- GC Cell Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung Suk Suh, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983967
- Sponsor's protocol ID
- ILC-IIT-07
- Status last verified
- Jun 2023
- First submitted
- 12 Mar 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03983967
- Acronym / sponsor ID
- ILC-IIT-07
- Conditions
- Liver Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GC Cell CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
| Arm | Type | Receives |
|---|---|---|
| Immuncell-LC group | Experimental | Biological: Immuncell-LCAdjuvant 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) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immuncell-LCActivated T lymphocyte | Biological | Immuncell-LC group |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Suk Suh, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immuncell-LC in people with Liver Transplantation, run by GC Cell Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.