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.
Study 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body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety and Tolerability — 28 Days post infusion Incidence of protocol defined Dose Limiting Toxicities (DLTs).
Long-term safety — Day of infusion through to Week 82 and up to 15 years post infusion Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.
Trial sites (10)
Facility
City
Region
Status
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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