Status:
RECRUITING
Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients
Lead Sponsor:
Quell Therapeutics Limited
Conditions:
Rejection; Transplant, Liver
Liver Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2040
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05234190
Start Date
January 21 2022
End Date
March 1 2040
Last Update
April 23 2024
Active Locations (10)
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1
H. Saint Luc
Brussels, Belgium
2
Hopital Erasme
Brussels, Belgium
3
UZ Leuven
Leuven, Belgium, 3000
4
H. Clinic Barcelona
Barcelona, Spain