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    Summary
    EudraCT Number:2021-000545-40
    Sponsor's Protocol Code Number:FELZ01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-02-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-000545-40
    A.3Full title of the trial
    Safety, Tolerability and Efficacy of Monoclonal CD38 Antibody Felzartamab in Late Antibody-Mediated Renal Allograft Rejection – A Phase 2 Pilot Trial
    Sicherheit, Verträglichkeit und Effektivität des monoklonalen CD38 Antikörpers Felzartamab bei später Antikörper-vermittelter Nierentransplantatabstoßung – Eine Phase 2 Pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability and Efficacy of the Therapeutic Antibody Felzartamab in Rejection Late After Kidney Transplantation
    Sicherheit, Verträglichkeit und Wirksamkeit des therapeutischen Antikörpers Felzartamab bei Abstoßung spät nach Nierentransplantation
    A.3.2Name or abbreviated title of the trial where available
    Felzartamab in late ABMR
    Felzartamab bei später ABMR
    A.4.1Sponsor's protocol code numberFELZ01
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMorphoSys AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitätsmedizin Berlin
    B.5.2Functional name of contact pointKlemens Budde (LKP)
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450514002
    B.5.5Fax number+4930450514902
    B.5.6E-mailnephro-intensiv@charite.de
    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 nameFelzartamab
    D.3.4Pharmaceutical form Lyophilisate 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 INNFelzartamab
    D.3.9.1CAS number 2197112-39-1
    D.3.9.2Current sponsor codeMOR202
    D.3.9.4EV Substance CodeSUB216362
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number65
    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) Yes
    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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Late active or chronic active antibody-mediated rejection
    E.1.1.1Medical condition in easily understood language
    Immunological rejection of a kidney transplant late after transplantation
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to evaluate the safety and tolerability of CD38 monoclonal antibody felzartamab in a prospective cohort of kidney transplant recipients diagnosed with late active or chronic active ABMR.
    E.2.2Secondary objectives of the trial
    The trial will evaluate preliminary efficacy of targeting CD38 in late active ABMR (secondary endpoints), and can be expected to provide a valuable basis for the potential design of a pivotal trial powered for the detection of clinical outcome differences.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Voluntary written informed consent
    Age >18 years (maximum: 70 years)
    Functioning living or deceased donor allograft after ≥180 days post-transplantation
    eGFR ≥20 ml/min/1.73 m2 (CKD-EPI formula)
    HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA).
    Active or chronic/active ABMR (±C4d in PTC) according to the Banff 2019 classification
    Molecular ABMR score (MMDx) ≥0.2
    E.4Principal exclusion criteria
    Patients actively participating in another clinical trial
    Age ≤18 years
    Female subject is pregnant or lactating or not on adequate contraceptive therapy
    ABO-incompatible transplant
    Index biopsy results:
    T-cell-mediated rejection classified Banff grade ≥I
    De novo or recurrent severe thrombotic microangiopathy
    Polyoma virus nephropathy
    De novo or recurrent glomerulonephritis
    Acute rejection treatment ≤3 month before screening
    Previous treatment with other CD38 monoclonal antibodies (e.g. daratumumab)
    Previous treatment with other immunomodulatory monoclonal/polyclonal antibodies (e.g. CD20 Ab rituximab, IL-6/IL-6R Ab) ≤3 months before study treatment
    Total bilirubin >2×the upper limit of normal [ULN], alanine transaminase and aspartate aminotransferase >2·5×ULN
    Haemoglobin <8 g/dL
    Thrombocytopenia: Platelets <100 G/L
    Leukopenia: Leukocytes <3 G/L
    Neutropenia: Neutrophils < 1.5 G/L
    Hypogammaglobulinemia: Serum IgG <400 mg/dL
    Active viral, bacterial or fungal infection precluding intensified immunosuppression
    Active malignant disease precluding intensified immunosuppressive therapy
    Latent or active tuberculosis (positive QuantiFERON-TB-Gold test)
    Administration of a live vaccine within 6 weeks of screening
    History of alcohol or illicit substance abuse
    Serious medical or psychiatric illness likely to interfere with participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of felzartamab in renal allograft recipients with ABMR on baseline immunosuppression
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the study period of 52 weeks
    E.5.2Secondary end point(s)
    - DSA/immunoglobulin levels
    Mean fluorescence intensity (MFI) of immunodominant DSA
    Changes in levels of the immunodominant DSA calculated from dilution experiments
    Number of detected DSA
    Total Ig (IgG, IgA, IgM) and IgG subclasses (IgG1, IgG2, IgG3, IgG4)
    Course of vaccination titers

    - Effect on leukocyte subsets in peripheral blood
    Circulating PC, NK cells, T and B cell subpopulations, expression of CD38 using non- crossreactive CD38 Ab clone HIT2

    - Results of follow-up protocol biopsies
    Morphological results:
    ABMR category (active vs. chronic active ABMR; C4d+ vs. C4d- ABMR)
    Extent of glomerular/pertibulular capillary microcirculation inflammation (g+ptc score)
    Transplant glomerulopathy (cg) and interstitial fibrosis/tubular atrophy scores
    Intragraft complement activation
    Patterns of intragraft cellular infiltrates (NK cells, PC, T cells, B cells)
    Gene expression analysis (Molecular Microscope® Diagnostic System, MMDx)
    Molecular classifiers/scores related to ABMR and T cell-mediated rejection
    Molecular classifiers/scores related to rejection in general
    Molecular classifiers/scores related to acute and chronic renal injury
    Archetypal analysis of rejection-related categories
    Pathogenesis-based transcripts (PBT) scores (cytotoxic T cell infiltration, γ-interferon effects, NK cell burden, epithelial cell damage

    - Effect on immunologic biomarkers
    CXCL9 and CXCL10 levels in blood and urine (Luminex-based detection)
    BAFF levels in blood (ELISA/Luminex)

    - Effect on measures of overall immunosuppression
    Torque Teno virus (TTV) levels in plasma (quantitative PCR)

    -Effect on clinical outcome parameters and surrogate endpoints:
    eGFR slope
    iBox clinical prediction score
    Protein excretion (protein/creatinine ratio)
    Death-censored/overall graft and patient survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    DSA/immunoglobulin levels: week 0, 12, 24, and 52

    Effect on leukocyte subsets in peripheral blood : week 0, 1, 4, 8, 12, 24, and 52

    Follow-up protocol biopsies: week 24 and 52

    Immunologic biomarkers: week 0, 12, 24, and 52

    Measures of overall immunosuppression: week 0, 12, 24, and 52

    Clinical outcome parameters and surrogate endpoints:
    -eGFR slope: over a period of 52 weeks (4-weekly measurements)
    -iBox clinical prediction score: at, 24 and 52 weeks
    -Protein excretion (protein/creatinine ratio): over 52 weeks (4-weekly measurements)
    -Death-censored/overall graft and patient survival: over 52 weeks
    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) 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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
    LVLS
    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 months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    None
    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 Decision2022-03-29
    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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