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Could a single cell treatment free liver transplant patients from lifelong drugs?

NCT ID NCT05234190

Disease control Sponsor: Quell Therapeutics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a personalized cell therapy called QEL-001 in 33 liver transplant recipients. The therapy uses a patient's own cells, modified to train the immune system to accept the donated liver. The goal is to see if it is safe and allows patients to stop taking anti-rejection medications without their body rejecting the liver.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Sep 2040

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

liver disorder liver failure Rejection, Psychology transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver diseases Liver failure Rejection; transplant, liver

Contacts and locations

Locations

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • G. Gergorio Maranon

    Madrid, Spain

  • H. Clinic Barcelona

    Barcelona, Spain

  • H. Saint Luc

    Brussels, Belgium

  • Hopital Erasme

    Brussels, Belgium

  • Hospital Reina Sofia

    Córdoba, Spain

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Queen Elizabeth Hospital

    Birmingham, United Kingdom

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • UZ Leuven

    Leuven, 3000, Belgium

More trials for these conditions

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