End-stage Liver DiseasePhase 1/2ThRILNCT02166177
Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients
A Phase 1/2 study testing Autologous regulatory T cell product in people with End-stage Liver Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End-stage Liver Disease
- What is being tested?
- Autologous regulatory T cell product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to 22 Jan 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- adult patients with end-stage liver disease listed for primary liver transplant;
- calculated MELD score ≤ 25 at time of transplantation
Who cannot join
- HIV or RNA-positive Hepatitis C Virus infection;
- autoimmune liver disease
- previous organ transplant
- Ebstein Virus and/or Cytomegalovirus sero-negativity
- chronic use of systemic immunosuppressants
- hepatocellular carcinoma outside Milano criteria
- leukocytes <1.5x10^9/L and/or platelets <50x10^9/L.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Evaluating the Safety and Efficacy Profile of Regulatory T Cell Therapy in Liver Transplant Recipients
'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation
Read the detailed description
Stage I: To evaluate the safety of administering TR002 to liver transplant recipients.
Stage II: To evaluate the efficacy of TR002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.
- Conditions
- End-stage Liver Disease
- Being tested
- Autologous regulatory T cell product
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous regulatory T cell productDrug
Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Regulatory T cell therapy | Experimental | Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose) Receives: Drug: Autologous regulatory T cell product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose limiting toxicities (DLTs)
rate of adverse events qualifying as dose limiting toxicities
Measured: 1 month after IMP administration
Graft Loss
Rate of cellular rejection
Measured: 24 months
Secondary outcomes (5)
Immunosuppressive doses
total dose of immunosuppressive medication administered
Measured: 24 months
Prevention of acute and chronic rejection
incidence of rejection episodes
Measured: 24 months
Acute and Chronic Toxicity
incidence of immunological reactions, biochemical disturbances
Measured: 24 months
Liver histology
liver biopsy analysis
Measured: 12 months
Rate of successful immunosuppressive drug withdrawal
total dose of immunosuppressive medication administered
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Giovanna Lombardi, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166177
- Sponsor's protocol ID
- Treg Liver Trial
- Acronym
- ThRIL
- Status last verified
- Jan 2019
- First submitted
- 16 Jun 2014
- Last updated
- 10 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Safety and Efficacy Profile of Regulatory T Cell Therapy in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT02166177
- Acronym / sponsor ID
- ThRIL / Treg Liver Trial
- Conditions
- End-stage Liver Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jun 2014
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 18 Jun 2014 (estimated)
- 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.
'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation
Detailed description
Stage I: To evaluate the safety of administering TR002 to liver transplant recipients.
Stage II: To evaluate the efficacy of TR002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Regulatory T cell therapy | Experimental | Drug: Autologous regulatory T cell productAutologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to give informed consent
- adult patients with end-stage liver disease listed for primary liver transplant;
- calculated MELD score ≤ 25 at time of transplantation
Key exclusion criteria (7 listed)
- HIV or RNA-positive Hepatitis C Virus infection;
- autoimmune liver disease
- previous organ transplant
- Ebstein Virus and/or Cytomegalovirus sero-negativity
- chronic use of systemic immunosuppressants
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 |
|---|---|---|
| Autologous regulatory T cell productAutologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus. | Drug | Autologous Regulatory T cell therapy |
Primary outcome
Rate of dose limiting toxicities (DLTs)
Time frame: 1 month after IMP administration
rate of adverse events qualifying as dose limiting toxicities
Graft Loss
Time frame: 24 months
Rate of cellular rejection
5 secondary outcomes
Immunosuppressive doses
Time frame: 24 months
Prevention of acute and chronic rejection
Time frame: 24 months
Acute and Chronic Toxicity
Time frame: 24 months
Liver histology
Time frame: 12 months
Rate of successful immunosuppressive drug withdrawal
Time frame: 24 months
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 10 Jan 2019.
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Acute-on-Chronic Liver Failure (ACLF)
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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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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.
Giovanna Lombardi, PhD study director
King's College London
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 Autologous regulatory T cell product in people with End-stage Liver Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 7 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 10 Jan 2019. 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 United Kingdom. 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?
Rate of dose limiting toxicities (DLTs) (time frame: 1 month after IMP administration). The study lists 2 primary outcomes in all. 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 10 Jan 2019.