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Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients
Sponsor: Quell Therapeutics Limited
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body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.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
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