Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients (LIBERATE)

  • STATUS
    Recruiting
  • End date
    Jun 24, 2038
  • participants needed
    33
  • sponsor
    Quell Therapeutics Limited
Updated on 24 March 2022
liver transplant

Summary

The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of allograft rejection following immunosuppression withdrawal in liver transplantation. QEL-001 is a product made from a liver transplant recipient's own immune 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.

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 be activated on recognition of HLA-A2 antigens present on the donated liver and subsequently induce and maintain immunological tolerance to the organ.

Details
Condition Rejection; Transplant, Liver, Liver Failure, Liver Diseases
Treatment QEL-001
Clinical Study IdentifierNCT05234190
SponsorQuell Therapeutics Limited
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Subject who received HLA A2-mismatch liver transplant 12 months to 5 years prior to study entry
Able and willing to use contraception

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
Subjects with history of autoimmune disease
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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