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

Phase 1

Completed

• Conditions: End-stage Liver Disease
• Interventions: Drug: Autologous regulatory T cell product

• Registration Number: NCT02166177
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Primary Completion: 2018-01-22
• Study Completion: 2018-01-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Regulatory T cell therapy	Autologous regulatory T cell product	Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)

Primary Outcome Measures

Name	Time	Method
Rate of dose limiting toxicities (DLTs)	1 month after IMP administration	rate of adverse events qualifying as dose limiting toxicities
Graft Loss	24 months	Rate of cellular rejection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kings College Hospital; 🇬🇧 London, United Kingdom