Using genetically modified cells to prevent liver transplant rejection
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.
This study is testing if a new type of cell therapy can help people who have received a liver transplant accept their new organ without needing medication to suppress their immune system.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Quell Therapeutics Limited Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 10 sites (Brussels and 9 other locations) |
| Trial ID | NCT05234190 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of QEL-001, an autologous CAR T regulatory cell therapy, in patients who have undergone HLA-A2 mismatched liver transplants. The trial is designed to assess how well these genetically modified cells can help the body accept the transplanted liver after immunosuppression is withdrawn. It is a multicenter, first-in-human, open-label, single-arm study focusing on patients who are HLA A2/A28 negative and have been stable on immunosuppression for at least 12 weeks. The goal is to induce and maintain immunological tolerance to the transplanted organ.
Who should consider this trial
Good fit: Ideal candidates are HLA A2/A28 negative individuals who have received an HLA A2-mismatch liver transplant between 12 months and 5 years prior to study entry.
Not a fit: Patients with severe cardiac or respiratory diseases, or those with a history of autoimmune diseases requiring immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for long-term immunosuppression in liver transplant patients.
How similar studies have performed: While the use of CAR T regulatory cells is a novel approach, similar studies have shown promise in other transplant settings, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent. * Subject who are HLA A2/A28 negative who have received HLA A2-mismatch liver transplant 12 months to 5 years prior to study entry. * Able and willing to use contraception. * Be on stable maintenance of immunosuppression for at least 12 weeks prior to study entry. Exclusion Criteria: * Severe cardiac, respiratory disease or any other major organ dysfunction. * Subjects with prior non-liver solid organ or hematopoietic stem cell transplant. * Known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug. * Positive serology for human immunodeficiency virus (HIV), active or latent tuberculosis (TB) or other clinically active local or systemic infection. * Use of investigational agents within 3 months of screening. * Subjects with history of autoimmune disease requiring use of immunosuppression or biologics within 24 months prior to study entry. * Subject with history of malignancy in the past 5 years. * Medical or social condition that is not compatible with adequate study follow-up and any other reason that, in the opinion of the Site Investigator or Medical Monitor, would render the subject unsuitable for participation in the study. * Protocol defined laboratory value for the following parameters: * Alanine aminotransferase (ALT) and either alkaline phosphatase (ALP) or gamma-glutamyl transferase (GGT), * Kidney function e.g. eGFR, * White blood cells, * Hemoglobin, * Platelets.
Where this trial is running
Brussels and 9 other locations
- H. Saint Luc — Brussels, Belgium (Recruiting)
- Hopital Erasme — Brussels, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- H. Clinic Barcelona — Barcelona, Spain (Recruiting)
- Hospital Reina Sofia — Córdoba, Spain (Recruiting)
- G. Gergorio Maranon — Madrid, Spain (Recruiting)
- Queen Elizabeth Hospital — Birmingham, United Kingdom (Recruiting)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
- Royal Free London NHS Foundation Trust — London, United Kingdom (Recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Quell Therapeutics Clinical Trials
- Email: contact@quell-tx.com
- Phone: +44(0)2070969012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.