Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients — LIBERATE  

Liver Diseases Clinical Trial

Official title: A Single-arm, Open-label, Multi-center, Phase I/II Study Evaluating the Safety and Clinical Activity of QEL-001, an Autologous CAR T Regulatory Cell Treatment Targeting HLA-A2, in HLA-A2/ A28neg Patients That Have Received an HLA-A2pos Liver Transplant.

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of liver transplant rejection following immunosuppression withdrawal. QEL-001 is a product made from a patients own cells, which are genetically modified and designed to help the transplant recipient's body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.

Clinical Trial Description

This study is a multicenter, first-in-human, open-label, single-arm study of an autologous CAR T regulatory (CAR-Treg) in HLA-A2 mismatched liver transplant recipients. The aim is for the CAR-Tregs to be activated on recognition of HLA-A2 antigens present on the donated liver and subsequently induce and maintain immunological tolerance to the organ. ;

Related Conditions & MeSH terms

• Liver Diseases
• Liver Failure
• Rejection; Transplant, Liver

• NCT number: NCT05234190
• Study type: Interventional
• Source: Quell Therapeutics Limited
• Contact: Quell Therapeutics Clinical Trials
• Phone: +44(0)2070969012
• Email: contact@quell-tx.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 21, 2022
• Completion date: March 2040