Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-001379-18
    Sponsor's Protocol Code Number:QEL-001-CLN-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-001379-18
    A.3Full title of the trial
    A single-arm, open-label, multi-centre, 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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II study of QEL-001 in A2-mismatch liver transplant patients
    A.4.1Sponsor's protocol code numberQEL-001-CLN-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05234190
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQuell Therapeutics Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportQuell Therapeutics Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuell Therapeutics Limited
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressTranslation and Innovation Hub, 84 Wood Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 0BZ
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailQEL-001-CLN-01@quell-tx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameQEL-001
    D.3.2Product code QEL-001
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot requested to date
    D.3.9.2Current sponsor codeQEL-001
    D.3.9.3Other descriptive nameAutologous T regulatory cells expressing an HLA-A2-specific chimeric antigen receptor
    D.3.9.4EV Substance CodeSUB218939
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 700
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of liver transplant rejection
    E.1.1.1Medical condition in easily understood language
    Prevention of liver transplant rejection
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10024715
    E.1.2Term Liver transplant rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of a single target dose of QEL-001
    E.2.2Secondary objectives of the trial
    To assess the clinical activity of QEL-001 (Part 2 only)
    To assess safety-related events
    To determine absence or presence of exposure to replication-competent lentivirus (RCL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects (regardless of gender) must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
    2. HLA A2/A28neg (including split antigens A68neg and A69neg) subjects who have received an A2pos liver transplant.
    3. Having received a liver transplant 12 months to 5 years prior to study entry with:
    a. No episodes of rejection in the previous 12 months (except early rejection taking place in the first 3 months post-transplantation.
    b. No previous episodes of rejection requiring lymphodepleting antibody therapy.
    4. Having alanine aminotransferase (ALT) <60 U/L and either alkaline phosphatase (ALP) <200 U/L or gamma-glutamyl transferase (GGT) <100 U/L.
    5. Having eGFR ≥ 40 mL/min/1.73 m2 using the MDRD formula.
    6. Having an adequate bone marrow (BM) function without requiring ongoing blood product(s) or granulocyte colony-stimulating factor (GCSF) and meeting the following criteria:
    a. Absolute neutrophil count ≥ 1.0 x 10e9/L
    b. Absolute lymphocyte count ≥ 0.3 x 10e9/L
    c. Leucocyte count ≥ 2.0 x 10e9/ L
    d. Haemoglobin ≥ 80 g/L
    e. Platelet greater or equal to 100 x 10e9/L
    7. Having an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    8. Able and willing to use a highly effective method of contraception (male subjects and female subjects with reproductive potential) from informed consent through and for at least 12 months.
    9. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening, prior to conditioning with rATG and prior/post QEL-001 infusion.
    10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    11. Being on stable maintenance of immunosuppression for at least 12 weeks prior to study entry
    E.4Principal exclusion criteria
    1. Having any medical condition that, in the opinion of the principal investigator (PI), would interfere with safe completion of the trial including:
    a. Severe cardiac disease, severe respiratory disease with O2 blood saturation <92%.
    b. Any other major organ dysfunction.
    2. Having received prior non-liver solid organ or hematopoietic stem cell transplant.
    3. Have had any major surgical intervention in the last 3 months prior to study entry (such as open surgeries requiring general anaesthetic).
    4. History of autoimmune disease requiring systemic immunosuppression, systemic disease modifying agents or biologics within the last 24 months prior to study entry.
    5. History of autoimmune hepatitis, primary sclerosing cholangitis or primary biliary cholangitis.
    6.Having any evidence of recurrent hepatocellular carcinoma (HCC)
    following clinical assessment; for subjects with liver explant histology
    showing a RETREAT score greater than 0 the clinical assessment should
    include a thoraco-abdominal radiological scan (CT or MRI according to
    local clinical practice) performed within 1 month prior to enrolment.
    7. History of HCC with high risk of recurrence defined as:
    a. For subjects who are <2 years post-transplant: a) RETREAT score greater than or equal to 3.
    b. For subjects who are 2-5 years post-transplant: a) RETREAT score greater than or equal to 4.
    c. Additional explant-based exclusion criteria: i) presence of diffuse HCC in explant; ii)
    presence of extrahepatic extension or macrovascular invasion; iii) diagnostics of
    cholangiocarcinoma; iv) subjects who have undergone a downstaging procedure pretransplantation.
    8. Having active primary or recurrent malignant disease or have been in remission from clinically significant malignancy for less than 5 years.
    a. Except subjects that have had a cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study.
    b. Except subjects that have had basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may participate in the study.
    9. Having urine protein to creatinine ratio > 25mg/mmol or > 50mg/mmol if the subject is already under dual therapy TAC/EVR.
    10. Having triglycerides ≥ 3.95 mmol/L (350 mg/dL) despite appropriate therapy.
    11. Having cholesterol ≥ 7.8 mmol/L (301.5 mg/dL) despite appropriate therapy.
    12. Having QTc > 450 msec for male subjects or QTc > 470 msec for female subjects or QTc > 480 msec in subjects with bundle branch block.
    13. Having any contraindications to receive rATG, EVR (notably subjects with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption), TAC or rituximab.
    14. Receiving any other concurrent investigational agents within 3 months prior study entry.
    15. Having an active infection as defined in the study protocol.
    16. Having previous history of human immunodeficiency virus (HIV).
    17. Evidence of active or latent tuberculosis (TB). After anti-TB treatment, patients with history of active or latent TB may become eligible according to national guidelines.
    18. Recent history of reactivation of Cytomegalovirus (CMV) defined as positive DNA test within 6 months prior entry to the study.
    19. Females who are pregnant (i.e., positive blood or urine β human Chorionic Gonadotropin (β- hCG) test) or lactating.
    20. Do not have:
    a. up-to-date vaccination status as per local immunization schedules/national guidelines (e.g., influenza and pneumococcal vaccination for >65 years old).
    b. any required vaccination (if required) at least 2 weeks prior to study entry, in accordance with national guidelines.
    21. Have known or suspected hypersensitivity or allergy to DMSO present in QEL-001 as excipients.
    22. Having a non-adequate bilateral venous access for leukapheresis, or not willing to undergo a central venous catheter insertion.
    23. Having contraindications to undergo a leukapheresis.
    24. Have any significant medical or social condition that, in the Investigator's opinion, may interfere with the subject’s optimal participation or compliance with the study procedure.
    25. Having history of liver cirrhosis or advanced fibrosis post-transplantation.
    26. Receiving prohibited medications that cannot be stopped at study entry.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of protocol-defined Dose-Limiting Toxicities (DLTs) within 28 days post infusion.
    • Incidence and severity of Treatment Emergent Adverse Events (TEAE) including serious adverse events (SAE) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed continuously throughout study.
    E.5.2Secondary end point(s)
    • Proportion of subjects that can be successfully withdrawn from IS defined as the percentage of subjects who have stable Liver Function Tests (LFTs) and are IS free for 2 months following Immunosuppression withdrawal.
    • Proportion of subjects that can be successfully withdrawn from IS defined as the percentage of subjects who have stable LFTs and are IS free for 1 year following Immunosuppression withdrawal.
    • Incidence and severity of infections from treatment to 1 year post full wean of all immune suppressive medication.
    • Proportion of subjects with detectable RCL assessed by polymerase chain reaction (PCR) to vesicular stomatitis virus G glycoprotein (VSV-G) protein [time frame: pre-treatment and Week 14, Week 26 and Week 54.
    • Proportion of subjects meeting criteria for operational tolerance defined as (1) successfully withdrawn from IS and remaining IS free for 1 year following Immunosuppression withdrawal; (2) having stable LFTs and (3) meeting histological criteria of operational tolerance.
    • Incidence rate composite efficacy failure from treatment to 1 year following Immunosuppression withdrawal. Composite efficacy failure endpoint is defined as AR, biopsy proven acute rejection (BPAR), reintroduction of IS or graft loss.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Incidence rate of composite efficacy failure will be assessed from treatment through week 82
    RCL detection is performed at Day 1, Week 14, Week 24, Week 52, and then LTFU month 6, month 12, month 24, month 36, month 48, month
    60, then yearly between years 6 to 15
    Infectious disease markers will be assessed at Screening, pre-treatment visits 3 and 4
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    Belgium
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the last subject’s visit (LPLV), which is the last visit of the LTFU which is the last subject’s Year 15 evaluation. A subject is considered to have completed the study if they have completed the last visit of the LTFU. Subjects that discontinue from the “Treatment and Primary follow-up" phase before W14 (for part 1) or before W82 (for part 2), will be enrolled into the LTFU as recommended by regulatory authority guidance and after consent has been obtained.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years16
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years16
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 42
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects enrolled to the study will be subject to long-term follow for a period of up to 15 years following participation in Part 1 or Part 2 of the study. No further study intervention is anticipated following the end of the study and consequently subjects will revert to standard of care as directed by their treating physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 03 05:57:05 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA