Treg Liver Trial
Research type
Research Study
Full title
‘First-in-Human’ Pilot Study, Evaluating the Safety and Efficacy Profile of Regulatory T cell Therapy in Liver Transplant Recipients.
IRAS ID
136768
Contact name
Alberto Sanchez-Fueyo
Contact email
Sponsor organisation
King's College London
Eudract number
2013-002858-77
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This is a clinical trial in patients undergoing liver transplantation. Research has shown that regulatory T-cells can induce tolerance to the graft in laboratory animals that have undergone organ transplantation. In this study, liver recipients will receive a single infusion of TR002, a cell therapy product that consists of regulatory T-cells that are grown and purified from the patients’ own blood. The trial aims to explore the feasibility, safety, and efficacy of TR002 as add-on immunosuppressive treatment in the context of liver transplantation.
The trial comprises two consecutive stages: Stage I is a dose escalation study investigating the safety and tolerability of two different doses (low dose and high dose) of TR002. This stage will establish which of these two doses is the maximum tolerated dose. Stage II will assess the efficacy of TR002. To this end, patients will be treated with the maximum tolerated dose of TR002 and then gradually withdrawn from their standard immunosuppressive drugs.
For Stage I, we plan to recruit 6 patients that could be expanded to 12 in case of symptoms of toxicities with the infusion. For Stage II up to 20 patients will be enrolled.REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0604
Date of REC Opinion
10 Jan 2014
REC opinion
Further Information Favourable Opinion