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

End-stage Liver Disease Clinical Trial

— ThRIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166177
• Other study ID #: Treg Liver Trial
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2014
• Est. completion date: January 22, 2018

Study information

• Verified date: January 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 22, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Liver Disease
• End-stage Liver Disease
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Kings College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunological biomarkers	immune monitoring analysis of blood samples investigating the effect of TR002 on blood cell immunophenotype	12 months
Primary	Rate of dose limiting toxicities (DLTs)	rate of adverse events qualifying as dose limiting toxicities	1 month after IMP administration
Primary	Graft Loss	Rate of cellular rejection	24 months
Secondary	Immunosuppressive doses	total dose of immunosuppressive medication administered	24 months
Secondary	Prevention of acute and chronic rejection	incidence of rejection episodes	24 months
Secondary	Acute and Chronic Toxicity	incidence of immunological reactions, biochemical disturbances	24 months
Secondary	Liver histology	liver biopsy analysis	12 months
Secondary	Rate of successful immunosuppressive drug withdrawal	total dose of immunosuppressive medication administered	24 months