Back to resultsSafety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients (ThRIL)
Primary Purpose
End-stage Liver Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Autologous regulatory T cell product
Sponsored by
About this trial
This is an interventional treatment trial for End-stage Liver Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Kings College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous Regulatory T cell therapy
Arm Description
Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)
Outcomes
Primary Outcome Measures
Rate of dose limiting toxicities (DLTs)
rate of adverse events qualifying as dose limiting toxicities
Graft Loss
Rate of cellular rejection
Secondary Outcome Measures
Immunosuppressive doses
total dose of immunosuppressive medication administered
Prevention of acute and chronic rejection
incidence of rejection episodes
Acute and Chronic Toxicity
incidence of immunological reactions, biochemical disturbances
Liver histology
liver biopsy analysis
Rate of successful immunosuppressive drug withdrawal
total dose of immunosuppressive medication administered
Full Information
NCT ID
NCT02166177
First Posted
June 16, 2014
Last Updated
January 9, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT02166177
Brief Title
Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients
Acronym
ThRIL
Official Title
Pilot Study Evaluating the Safety and Efficacy Profile of Regulatory T Cell Therapy in Liver Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
4. Oversight
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous Regulatory T cell therapy
Arm Type
Experimental
Arm Description
Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)
Intervention Type
Drug
Intervention Name(s)
Autologous regulatory T cell product
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of dose limiting toxicities (DLTs)
Description
rate of adverse events qualifying as dose limiting toxicities
Time Frame
1 month after IMP administration
Title
Graft Loss
Description
Rate of cellular rejection
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Immunosuppressive doses
Description
total dose of immunosuppressive medication administered
Time Frame
24 months
Title
Prevention of acute and chronic rejection
Description
incidence of rejection episodes
Time Frame
24 months
Title
Acute and Chronic Toxicity
Description
incidence of immunological reactions, biochemical disturbances
Time Frame
24 months
Title
Liver histology
Description
liver biopsy analysis
Time Frame
12 months
Title
Rate of successful immunosuppressive drug withdrawal
Description
total dose of immunosuppressive medication administered
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Immunological biomarkers
Description
immune monitoring analysis of blood samples investigating the effect of TR002 on blood cell immunophenotype
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanna Lombardi, PhD
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
Kings College Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients
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