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    Summary
    EudraCT Number:2021-001680-24
    Sponsor's Protocol Code Number:TCD601G201
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-20
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-001680-24
    A.3Full title of the trial
    A 60 month, single-arm, proof-of-concept study to induce allogeneic tolerance in deceased donor liver transplant recipients using siplizumab, an anti-CD2 antibody in combination with cyclophosphamide and splenectomy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate whether treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.
    A.4.1Sponsor's protocol code numberTCD601G201
    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 SponsorITB-MED AB
    B.1.3.4CountrySweden
    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 supportIBT-MED AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationITB-MED AB
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressHagaplan 4
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code113 68
    B.5.3.4CountrySweden
    B.5.4Telephone number841002887
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1931
    D.3 Description of the IMP
    D.3.1Product nameSiplizumab
    D.3.2Product code TCD601
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNSIPLIZUMAB
    D.3.9.1CAS number 288392-69-8
    D.3.9.2Current sponsor codeTCD601
    D.3.9.3Other descriptive nameSIPLIZUMAB
    D.3.9.4EV Substance CodeSUB33504
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    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
    Prophylaxis against liver allograft rejection following tolerance
    induction
    E.1.1.1Medical condition in easily understood language
    Liver failure
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10050434
    E.1.2Term Prophylaxis against liver transplant rejection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether a siplizumab-based regimen can induce allogeneic tolerance in deceased donor liver transplant recipients.
    E.2.2Secondary objectives of the trial
    To explore the safety of siplizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant.
    2. MELD score <30 on recent evaluation within 60 days of screening
    3. Stable cardio-pulmonary status per the judgement of the investigator and eligible for transplantation per local regulations.
    4. EBV sero-positive.
    5. SARS-CoV-2 negative.
    6. Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF.
    E.4Principal exclusion criteria
    1. Use of other investigational drugs (or enrollment in another investigational drug study) within 30 days of screening or 5 half-lives of the medication, whichever is longer
    2. History of hypersensitivity to any of the study treatments or their excipients or to drugs of similar chemical classes (e.g., siplizumab, TAC, cyclophosphamide or MMF)
    3. End stage liver disease of autoimmune origin, including autoimmune hepatitis, primary biliary cholangitis or primary sclerosing cholangitis.
    4. Subjects with leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (platelet count < 70,000/mm3) at baseline
    5. Sero-positive for HIV-1 or HBsAg. Subjects who are sero-positive for Hepatitis C virus are excluded without proof of sustained viral response (SVR) after anti-HCV treatment
    6. Subjects with a history of TB or latent TB infection as detected by Quantiferon Gold Plus IGRA (or current standard interferon gamma release assay for TB)
    7. Subjects with extrahepatic malignancy or history of same, other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
    8. Cardiac ejection fraction ≤ 40% within 6 months or clinical evidence of cardiac insufficiency
    9. Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirement outlined in the protocol.
    10. Subjects with any other clinically significant medical condition or laboratory abnormality that would, in the judgment of the investigator interfere with the subject’s ability to participate in the study.
    11. Subjects who have received any live-attenuated vaccine within 2 months of planned transplant.
    12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
    13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant are excluded, unless they are using highly effective methods of contraception during dosing and for 24 weeks after the study medication has been stopped.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients who are free from immunosuppression at Month 30 post-transplant.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months post-transplant.
    E.5.2Secondary end point(s)
    - Composite efficacy failure rate of treated biopsy proven acute rejection (tBPAR), graft loss or death at Month 30
    - The proportion of patients who remain off immunosuppression for at least 12 months
    - Incidence, severity, and treatment of acute rejection (derived from the biopsy, rejection, adverse event (AE) and treatment Case Report Forms (CRFs))
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 months.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) No
    E.7.1.1First administration to humans No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LSLV (Month 60 or End of Study)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months60
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state12
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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)
    The study is 60 months comprising of a core period to Month 30 (primary analysis) and a follow-up period to Month 60. There are no plans for treatment or care of the study subjects after that timepoint.
    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 Decision2022-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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