Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients
NCT ID: NCT05234190
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2022-01-21
2040-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Quell Therapeutics Limited
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Chantal De Reyck
Role: primary
Francoise Smits
Role: primary
Luca Jacobs
Role: backup
Claire Evers
Role: primary
Sofie Vets
Role: backup
Laia Escude
Role: primary
Clara Linares
Role: primary
Paloma Fernandez
Role: primary
Diana Hull
Role: primary
Shaida Begum
Role: backup
Ann-Marie O'sullivan
Role: primary
Aileen Marshall, MBChB (Hons) and PhD
Role: primary
Bernadette Solis
Role: primary
Other Identifiers
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2021-001379-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QEL-001-CLN-01
Identifier Type: -
Identifier Source: org_study_id
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