Rejection; Transplant, LiverPhase 1/2LIBERATENCT05234190
Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients
A Phase 1/2 study testing QEL-001 in people with Rejection; Transplant, Liver and Liver Failure, run by Quell Therapeutics Limited at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rejection; Transplant, Liver, Liver Failure, Liver Diseases
- What is being tested?
- QEL-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 21 Jan 2022to Sep 2040
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Royal Free London NHS Foundation Trust
London, NW3 2QG
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Belgium3 sites
H. Saint Luc
Brussels
Hopital Erasme
Brussels
UZ Leuven
Leuven, 3000
Spain3 sites
H. Clinic Barcelona
Barcelona
Hospital Reina Sofia
Córdoba
G. Gergorio Maranon
Madrid
About this study
Official title: A Single-arm, Open-label, Multi-center, Phase I/II Study Evaluating the Safety and Clinical Activity of QEL-001, an Autologous CAR T Regulatory Cell Treatment Targeting HLA-A2, in HLA-A2/ A28neg Patients That Have Received an HLA-A2pos Liver Transplant.
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.
Read the 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 be activated on recognition of HLA-A2 antigens present on the donated liver and subsequently induce and maintain immunological tolerance to the organ.
- Conditions
- Rejection; Transplant, Liver, Liver Failure, Liver Diseases
- Being tested
- QEL-001
- Keywords
- Regulatory T cells, Chimeric Antigen Receptor, Autologous, Genetically modified cells
- Medical subject headings
- Rejection, Psychology, Liver Failure, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QEL-001Drug
Also called HLA-A2 CAR-Treg
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 group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: QEL-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of protocol defined Dose Limiting Toxicities (DLTs).
Measured: 28 Days post infusion
Long-term safety
Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.
Measured: Day of infusion through to Week 82 and up to 15 years post infusion
Secondary outcomes (3)
Immunosuppression related outcome
Ability to withdraw immunosuppression (IS) as measured by the percentage of subjects who have stable Liver Function Tests and are IS free at two months and at one year following IS withdrawal.
Measured: 2 months and 1 year post withdrawal of immune suppression
Tolerance related outcome
Ability to achieve operational tolerance as measured by the proportion of subjects meeting the clinical, biochemical and histological operational tolerance criteria at one year following IS withdrawal.
Measured: 1 year following immune suppression withdrawal
Composite efficacy failure outcome
Proportion of subjects with composite event: acute rejection (AR), biopsy proven acute rejection (BPAR), reintroduction of IS or graft loss.
Measured: 1 year following immune suppression withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start21 Jan 2022
- Primary completion25 Feb 2026
- Study completionSep 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rejection; Transplant, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quell Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234190
- Sponsor's protocol ID
- QEL-001-CLN-01
- Other IDs
- 2021-001379-18
- Acronym
- LIBERATE
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multi-center, Phase I/II Study Evaluating the Safety and Clinical Activity of QEL-001, an Autologous CAR T Regulatory Cell Treatment Targeting HLA-A2, in HLA-A2/ A28neg Patients That Have Received an HLA-A2pos Liver Transplant.
- ClinicalTrials.gov ID
- NCT05234190
- Acronym / sponsor ID
- LIBERATE / QEL-001-CLN-01
- Conditions
- Rejection; Transplant, Liver, Liver Failure, Liver Diseases
- Keywords
- Regulatory T cells, Chimeric Antigen Receptor, Autologous, Genetically modified cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Quell Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- Sep 2040 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 be activated on recognition of HLA-A2 antigens present on the donated liver and subsequently induce and maintain immunological tolerance to the organ.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: QEL-001 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QEL-001Also: HLA-A2 CAR-TregQEL-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. | Drug | Treatment group |
Primary outcome
Safety and Tolerability
Time frame: 28 Days post infusion
Incidence of protocol defined Dose Limiting Toxicities (DLTs).
Long-term safety
Time frame: 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.
3 secondary outcomes
Immunosuppression related outcome
Time frame: 2 months and 1 year post withdrawal of immune suppression
Tolerance related outcome
Time frame: 1 year following immune suppression withdrawal
Composite efficacy failure outcome
Time frame: 1 year following immune suppression withdrawal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QEL-001 in people with Rejection; Transplant, Liver and Liver Failure, run by Quell Therapeutics Limited at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 28 Days post infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.