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    Summary
    EudraCT Number:2021-005192-39
    Sponsor's Protocol Code Number:202100663
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-005192-39
    A.3Full title of the trial
    Programmed death ligand 1 (PD-L1) PET imaging in patients with (Diffuse) Large B-cell lymphoma who are treated with CD19-directed CAR T-cell therapy
    Programmed death ligand (PD-L1) PET-beeldvormingsonderzoek in patiënten met (diffuus) grootcellig B-cellymfoom die behandeld worden met CD19-gerichte CAR T-celtherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PD-L1 PET imaging study during CAR T-cell therapy
    PD-L1 PET-beeldvormingsonderzoek tijdens CAR T-celtherapie
    A.4.1Sponsor's protocol code number202100663
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportGenentech Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportSiemens
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointTrial Data Center
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialbureauhematologie@onco.umcg.nl
    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 name89Zr-atezolizumab
    D.3.4Pharmaceutical form 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 INNMPDL3280A
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2.5
    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 Yes
    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 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.IMP: 2
    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 nameAtezolizumab (MPDL3280A)
    D.3.4Pharmaceutical form 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 INNMPDL3280A
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 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 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
    Patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of therapy who fulfill the eligibility criteria for CD19-directed CAR T-cell therapy according the Immune Effector Cell Working Group Tumorboard.
    Patiënten met recidiverend/refractair grootcellig B-cel lymfoom (LBCL) ondanks twee of meer eerdere therapielijnen die voldoen aan de criteria voor CD19-gerichte CAR T-cel therapie volgens de Immune Effector Cell Working Group Tumorboard.
    E.1.1.1Medical condition in easily understood language
    Patients with relapsed/refractory large B-cell lymphoma after two or more prior lines of therapy and qualify for CD19-directed CAR T-cell therapy
    Patiënten met recidiverende/refractaire grootcellig B-cel lymfoom na twee of meer therapielijnen die in aanmerking komen voor CD19-gerichte CAR T-cel therapie
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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
    - to study the expression of PD-L1 in normal tissue and lymphoma lesions before CD19-directed CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT imaging and to correlate pretreatment 89Zr-atezolizumab uptake to response to CD19-directed CAR T-cell therapy and thereby identify clinically relevant PD-L1 expression.
    - To study whether the amount of 89Zr-atezolizumab uptake, measured by the intensity of 89Zr-atezolizumab PET/CT imaging (SUV), can be used to differentiate between lymphoma activity and treatment-related inflammatory reaction (histiocytic/sarcoid-like reaction) in patients with an end-of-treatment 18F-FDG-positive PET/CT signal.
    - Het bestuderen van de expressie van PD-L1 in normaal weefsel en lymfoom laesies voor CD19-gerichte CAR T-cel therapie in LBCL patiënten door 89Zr-atezolizumab PET/CT beeldvorming en om de opname van 89Zr-atezolizumab voor behandeling te correleren aan de respons op CD19-gerichte CAR T-cel therapy om op deze manier klinisch relevante PD-L1 expressie te identificeren
    - Het bestuderen of de hoeveelheid opname van 89Zr-atezolizumab, gedefineerd als de intensiteit van het 89Zr-atezolizumab PET/CT beeldvormingsonderzoek, gebruikt kan worden om te differentieren tussen lymfoomactiviteit en behandeling-gerelateerde inflammatoire reactie (histocytaire/sarcoïd-like reactie) in patiënten met een positief 18F-FDG PET/CT signaal aan het eind van de behandeling.
    E.2.2Secondary objectives of the trial
    To correlate the pretreatment 89Zr-atezolizumab distribution to CAR T-cell peak expansion and persistence

    To correlate the pretreatment 89Zr-atezolizumab uptake to CAR T-cell therapy related grade 1-5 adverse events (cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS))

    To correlate tumor 89Zr-atezolizumab uptake with tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy

    To compare the 89Zr-atezolizumab distribution in irradiated versus non-irradiated lymphoma lesions in patients who require radiotherapy as a bridging strategy prior to CAR T-cell infusion. If possible, these results will be compared to tumor and immune cell PD-L1 expression on a fresh contemporaneous tumor biopsy of an irradiated lymphoma lesion

    To determine the incidence of a treatment-related inflammatory signal on 18F-FDG-PET/CT scan (histiocytic/sarcoid-like reaction) after CAR T-cell therapy
    - Om de distributie van 89Zr-atezolizumab voor behandeling te correleren aan de CAR T-cel piekexpansie en persistentie
    - Om de opname van 89Zr-atezolizumab voor behandeling te correleren aan CAR T-celtherapie gerelateerde grade 1-5 bijwerkingen (cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS))
    - Om de opname van 89Zr-atezolizumab in de tumor te correleren aan PD-L1 expressie van de tumor en immuuncellen, beoordeeld door het uitvoeren van immunohistochemie op een tumorbiopt
    - Om de 89Zr-atezolizumab distributie in een bestraalde vs een niet-bestraalde lymfoomlaesie te vergelijken bij patiënten die radiotherapie als bridging strategy krijgen voorafgaand aan CAR T-infusie. Indien mogelijk, zullen deze resultaten vergeleken worden met een tumorbiopt.
    - Om de incidentie van behandeling-gerelateerde inflammatoire signaal op een 18F-FDG PET/CT scan (histiocytaire/sarcoïd-like reactie) na CAR T-celtherapie te bepalen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, subject must meet the following:
    1. Histologically confirmed LBCL and associated subtypes, defined by WHO 2016 classification
    2. Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
    3. Measurable disease, as defined by Lugano criteria
    4. If has history of CNS disease, then must have no signs or symptoms of CNS disease, no active disease on magnetic resonance imaging (MRI) and absence of large cell lymphoma in cerebral spinal fluid (CSF) on cytospin preparation and flow cytometry, regardless of the number of white blood cells.
    5. If has history of cerebral vascular accident (CVA)
    a. The CVA event must be >12 months prior to apheresis
    b. Any neurological deficits must be stable
    6. Signed informed consent.
    7. Age ≥18 at the time of signing informed consent.
    8. Life expectancy ≥12 weeks.
    9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    10. Ability to comply with the protocol.
    11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet de proefpersoon aan het volgende voldoen:
    1. Histologisch bevestigde LBCL en bijbehorende subtypes, gedefinieerd door WHO 2016-classificatie
    2. Tumorlaesie(s) waarvan een histologische biopsie veilig kan worden verkregen volgens standaard procedure.
    3. Meetbare ziekte, zoals gedefinieerd door Lugano-criteria
    4. Als er sprake is van een voorgeschiedenis van CZS-ziekte heeft, dan mogen er geen tekenen of symptomen van CZS-ziekte zijn, geen actieve ziekte op magnetische resonantie beeldvorming (MRI) en afwezigheid van grootcellig lymfoom in cerebrale spinale vloeistof (CSF) op cytospin en flowcytometrie, ongeacht het aantal witte bloedcellen.
    5. Als er sprake is van een voorgeschiedenis met cerebraal vasculair accident (CVA), dan moet de CVA>12 maanden voorafgaand aan de aferese plaats hebben gevonden en eventuele neurologische afwijkingen moeten stabiel zijn
    6. Ondertekend informed consent
    7. Leeftijd ≥18 jaar op het moment van ondertekening van het informed consent
    8. Levensverwachting ≥12 weken.
    9. Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
    10. Cooperatief zijn met het protocol
    11. Voor vrouwelijke patiënten van vruchtbare leeftijd en mannelijke patiënten met partners in de vruchtbare leeftijd, moet er akkoord zijn (door patiënt en/of partner) om een ​​zeer effectieve vorm van anticonceptie te gebruiken (dwz een vorm die resulteert in een laag percentage mislukkingen [< 1% per jaar] bij consequent en correct gebruik).
    E.4Principal exclusion criteria
    1. Signs or symptoms of active infection within 2 weeks prior to 89Zr-atezolizumab injection, unless treated to resolution.
    2. Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g. blinatumomab).
    3. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
    4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of 89Zr-atezolizumab, or that may affect the interpretation of the results or render the patient at high risk from complications.
    5. Pregnant or lactating women.
    6. HIV-positive patients
    1. Tekenen of symptomen van actieve infectie binnen 2 weken voorafgaand aan 89Zr-atezolizumab-injectie, tenzij behandeld tot genezing.
    2. Eerdere CD19-gerichte CAR T-celtherapie of andere bispecifieke antilichamen die zich richten op de CD19-receptor (bijv. blinatumomab).
    3. Voorgeschiedenis van ernstige allergische, anafylactische of andere overgevoeligheidsreacties op chimere of gehumaniseerde antilichamen of fusie-eiwitten.
    4. Elke andere ziekte, metabole disfunctie, bevinding van lichamelijk onderzoek of klinische laboratoriumbevindingen die een redelijk vermoeden van een ziekte of aandoening geven die een contra-indicatie vormen voor het gebruik van 89Zr-atezolizumab, of die de interpretatie van de resultaten kunnen beïnvloeden of de patiënt een hoog risico kunnen geven op complicaties.
    5. Zwangere of borstvoeding gevende vrouwen.
    6. HIV-positieve patiënten
    E.5 End points
    E.5.1Primary end point(s)
    - to study the expression of PD-L1 in normal tissue and lymphoma lesions before CD19-directed CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT imaging and to correlate pretreatment 89Zr-atezolizumab uptake to response to CD19-directed CAR T-cell therapy and thereby identify clinically relevant PD-L1 expression. Heterogeneity of 89Zr-atezolizumab uptake will be evaluated by measuring standardized uptake value (SUV) on the 89Zr-atezolizumab PET/CT scan.
    - to study whether the amount of 89Zr-atezolizumab uptake, measured by the intensity of 89Zr-atezolizumab PET/CT imaging (SUV), can be used to differentiate between lymphoma activity and treatment-related inflammatory signal (histiocytic/sarcoid-like reaction) in patients with an end-of-treatment 18F-FDG-positive PET/CT signal. Confirmation of the presence of treatment-related inflammatory reaction (histiocytic/sarcoid-like reaction) will be determined by an experienced pathologist on a fresh contemporaneous biopsy of the positive FDG-PET lesion or in case of non-accessibility of the lesion by an experienced clinician via a wait-and-see strategy with repeated 18F-FDG PET/CT scans.
    - Het bestuderen van de expressie van PD-L1 in normaal weefsel en lymfoom laesies voor CD19-gerichte CAR T-cel therapie in LBCL patiënten door 89Zr-atezolizumab PET/CT beeldvorming en om de opname van 89Zr-atezolizumab voor behandeling te correleren aan de respons op CD19-gerichte CAR T-cel therapy om op deze manier klinisch relevante PD-L1 expressie te identificeren. Heterogeniteit van de 89Zr-atezolizumab opname zal geëvalueerd worden door het meten van de gestandaardiseerde opname op de 89Zr-atezolizumab PET/CT-scan.
    - Het bestuderen of de hoeveelheid opname van 89Zr-atezolizumab, gedefineerd als de intensiteit van het 89Zr-atezolizumab PET/CT beeldvormingsonderzoek, gebruikt kan worden om te differentieren tussen lymfoomactiviteit en behandeling-gerelateerde inflammatoire reactie (histocytaire/sarcoïd-like reactie) in patiënten met een positief 18F-FDG PET/CT signaal aan het eind van de behandeling. De aanwezigheid van een behandeling-gerelateerde inflammatoire reactie (histiocytaire/sarcoïd-like reactie) zal bepaald worden door een ervaren patholoog op een vers tumorbiopt van de positieve FDG-PET laesie of in het geval dat een biopt nemen niet mogelijk is door een ervaren klinicus door een afwachtend beleid met herhaalde 18F-FDG PET/CT-scans.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day -15 to -6, where day 0 is CAR T-infusie.
    Day +X, in case of a suspected relapse.
    Dag 15 tot -6, waar dag 0 de dag van CAR T-infusie is.
    Dag +X, in het geval van een verdenking op terugkeer van ziekte.
    E.5.2Secondary end point(s)
    - to correlate the pretreatment 89Zr-atezolizumab distribution, as measured by the uptake of 89Zr-atezolizumab on PET/CT imaging in lymphoma lesions, to CAR T-cell peak expansion and persistence as measured in peripheral blood.
    - To correlate the pretreatment 89Zr-atezolizumab uptake to CAR T-cell related grade 1-5 adverse events (cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)). Heterogeneity of 89Zr-atezolizumab uptake will be evaluated by measuring SUV on the 89Zr-atezolizumab PET/CT scan. CAR-T cell therapy related toxicities such as CRS and ICANS will be assessed using 2018 ASBMT Consensus Grading (24).
    - to correlate tumor 89Zr-atezolizumab uptake with tumor and tumor infiltrating cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy. Heterogeneity of 89Zr-atezolizumab uptake will be evaluated by measuring standardized uptake value (SUV) on the 89Zr-atezolizumab PET/CT scan.
    - To compare the 89Zr-atezolizumab distribution in irradiated versus non-irradiated lymphoma lesions in patients who require radiotherapy as a bridging strategy prior to CAR T-cell infusion. If possible, these results will be compared to tumor and tumor infiltrating cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy of an irradiated lymphoma lesion.
    - To determine the incidence of a treatment-related inflammatory signal on 18F-FDG PET/CT scan (histiocytic/sarcoid-like reaction) after CAR T-cell therapy. Confirmation of the presence of treatment-related inflammatory reaction (histiocytic/sarcoid-like reaction) will be determined by an experienced pathologist on a fresh contemporaneous biopsy of the positive 18F-FDG-PET/CT lesion or in case of non-accessibility of the lesion by an experienced clinician via a wait-and-see strategy with repeated 18F-FDG-PET/CT scans.
    - Om de distributie van 89Zr-atezolizumab voor behandeling , gemeten door de opname van 89Zr-atezolizumab op PET/CT beeldvormingsonderzoek in lymfoomlaesies, te correleren aan de CAR T-cel piekexpansie en persistentie
    - Om de opname van 89Zr-atezolizumab voor behandeling te correleren aan CAR T-celtherapie gerelateerde grade 1-5 bijwerkingen (cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS))Heterogeniteit van de 89Zr-atezolizumab opname zal geëvalueerd worden door het meten van de gestandaardiseerde opname (SUV) op de 89Zr-atezolizumab PET/CT-scan. CAR T-celtherapie gerelateerde toxiciteit, zoals CRS en ICANS zal beoordeeld worden volgende 2018 ASBMT Consensus grading.
    - Om de opname van 89Zr-atezolizumab in de tumor te correleren aan PD-L1 expressie van de tumor en immuuncellen, beoordeeld door het uitvoeren van immunohistochemie op een tumorbiopt. Heterogeniteit van de 89Zr-atezolizumab opname zal geëvalueerd worden door het meten van de gestandaardiseerde opname op de 89Zr-atezolizumab PET/CT-scan.
    - Om de 89Zr-atezolizumab distributie in een bestraalde vs een niet-bestraalde lymfoomlaesie te vergelijken bij patiënten die radiotherapie als bridging strategy krijgen voorafgaand aan CAR T-infusie. Indien mogelijk, zullen deze resultaten vergeleken worden met PD-L1 expressie van tumor en tumor-infiltrerende cellen, beoordeeld door immunohistochemie op een vers biopt van een bestraalde lymfoomlaesie.
    - Om de incidentie van behandeling-gerelateerde inflammatoire signaal op een 18F-FDG PET/CT scan (histiocytaire/sarcoïd-like reactie) na CAR T-celtherapie te bepalen. De aanwezigheid van een behandeling-gerelateerde inflammatoire reactie (histiocytaire/sarcoïd-like reactie) zal bepaald worden door een ervaren patholoog op een vers tumorbiopt van de positieve FDG-PET laesie of in het geval dat een biopt nemen niet mogelijk is door een ervaren klinicus door een afwachtend beleid met herhaalde 18F-FDG PET/CT-scans.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day -15 to -6, 0, +5, +7, +14, +28, +30
    Day +X, in case of a suspected relapse
    Dag -15 tot -6, 0, +5, +7, +14, +28, +30
    Dag +X, in het geval van een verdenking op terugkeer van ziekte.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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.8.3 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 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 state20
    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 Decision2022-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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