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ACTIVE NOT RECRUITING
NCT05234190
PHASE1/PHASE2

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

Sponsor: Quell Therapeutics Limited

View on ClinicalTrials.gov

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body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2022-01-21

Completion Date

2040-09

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DRUG

QEL-001

QEL-001 is an autologous therapy that is composed of engineered regulatory T cells transduced with a lentiviral vector containing a CAR directed against HLA-A2. Treatment will be given via an IV infusion.

Locations (10)

H. Saint Luc

Brussels, Belgium

Hopital Erasme

Brussels, Belgium

UZ Leuven

Leuven, Belgium

H. Clinic Barcelona

Barcelona, Spain

Hospital Reina Sofia

Córdoba, Spain

G. Gergorio Maranon

Madrid, Spain

Queen Elizabeth Hospital

Birmingham, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom