Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients (ThRIL)

January 9, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Regulatory T cell therapy
Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)
Drug: Autologous regulatory T cell product
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of dose limiting toxicities (DLTs)
Time Frame: 1 month after IMP administration
rate of adverse events qualifying as dose limiting toxicities
1 month after IMP administration
Graft Loss
Time Frame: 24 months
Rate of cellular rejection
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunosuppressive doses
Time Frame: 24 months
total dose of immunosuppressive medication administered
24 months
Prevention of acute and chronic rejection
Time Frame: 24 months
incidence of rejection episodes
24 months
Acute and Chronic Toxicity
Time Frame: 24 months
incidence of immunological reactions, biochemical disturbances
24 months
Liver histology
Time Frame: 12 months
liver biopsy analysis
12 months
Rate of successful immunosuppressive drug withdrawal
Time Frame: 24 months
total dose of immunosuppressive medication administered
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological biomarkers
Time Frame: 12 months
immune monitoring analysis of blood samples investigating the effect of TR002 on blood cell immunophenotype
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London

Investigators

  • Study Director: Giovanna Lombardi, PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

January 22, 2018

Study Completion (Actual)

January 22, 2018

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treg Liver Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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