Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients
NCT05234190 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2026-02-24
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body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.
Conditions
- Rejection; Transplant, Liver
- Liver Failure
- Liver Diseases
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.
Sponsors & Collaborators
-
Quell Therapeutics Limited
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-21
- Primary Completion
- 2026-02-28
- Completion
- 2040-09-30
Countries
- Belgium
- Spain
- United Kingdom
Study Locations
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