Skip to main content
OpenTrials
Completed

NCT Number: NCT02166177

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

'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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End-Stage Liver DIsease Digestive System Diseases End Stage Liver Disease Hepatic Insufficiency Liver Diseases Liver Failure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kings College Hospital

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous regulatory T cell product

Drug

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 outcomes

  1. Rate of dose limiting toxicities (DLTs)

    Time frame: 1 month after IMP administration

    rate of adverse events qualifying as dose limiting toxicities

  2. Graft Loss

    Time frame: 24 months

    Rate of cellular rejection

Secondary outcomes

  1. Immunosuppressive doses

    Time frame: 24 months

    total dose of immunosuppressive medication administered

  2. Prevention of acute and chronic rejection

    Time frame: 24 months

    incidence of rejection episodes

  3. Acute and Chronic Toxicity

    Time frame: 24 months

    incidence of immunological reactions, biochemical disturbances

  4. Liver histology

    Time frame: 12 months

    liver biopsy analysis

  5. Rate of successful immunosuppressive drug withdrawal

    Time frame: 24 months

    total dose of immunosuppressive medication administered

Other outcomes

  1. Immunological biomarkers

    Time frame: 12 months

    immune monitoring analysis of blood samples investigating the effect of TR002 on blood cell immunophenotype

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Official study title

Pilot Study Evaluating the Safety and Efficacy Profile of Regulatory T Cell Therapy in Liver Transplant Recipients

Acronym: ThRIL

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2014
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.