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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2016-003841-27
    Sponsor's Protocol Code Number:MDNA-55-05
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-04
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-003841-27
    A.3Full title of the trial
    An Open-Label Non-Randomized, Multi-Center Phase-2 Study of
    Convection-Enhanced Delivery (CED) of MDNA55 in Adults with
    Recurrent or Progressive Glioblastoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of MDNA55 in adults with a brain tumour
    A.4.1Sponsor's protocol code numberMDNA-55-05
    A.5.4Other Identifiers
    Name:BB IND 7004Number:USA IND number
    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 SponsorMedicenna Therapeutics Inc.
    B.1.3.4CountryCanada
    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 supportMedicinna Therapeutics Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedicenna Therapeutics Inc.
    B.5.2Functional name of contact pointClinical department, Medicenna
    B.5.3 Address:
    B.5.3.1Street Address1920 Yonge Street, 2nd Floor Toronto, ON
    B.5.3.2Town/ cityToronto
    B.5.3.3Post codeM4S 3E2
    B.5.3.4CountryCanada
    B.5.4Telephone number001647346 7867
    B.5.6E-mailnmerchant@medicenna.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/553
    D.3 Description of the IMP
    D.3.2Product code MDNA55
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracerebral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone
    D.3.9.1CAS number None
    D.3.9.2Current sponsor codeMDNA55
    D.3.9.3Other descriptive nameIL4(38-37)-PE38KDEL [circularly permuted Interleukin-4 (cpIL4) fused to a modified version of the Pseudomonas aeruginosa exotoxin A (PE)]
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 Yes
    D.3.11.13.1Other medicinal product typeA fusion protein consisting of a targeting domain linked to a proapoptotic cell-killing payload.
    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
    Glioblastoma
    E.1.1.1Medical condition in easily understood language
    Brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective response rate (ORR) per a modified RANO criteria
    following an intra- and peritumoral infusion CED of MDNA55 using CED
    relative to pre-operative planning MRI (baseline)
    E.2.2Secondary objectives of the trial
    To assess the safety of MDNA55 following CED in adult subjects with GB at first recurrence following standard therapy.

    To assess overall survival (OS) in these subjects

    To assess progression-free survival (PFS; using iRANO criteria) in these subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects must be ≥ 18 years old and have a life expectancy ≥ 12 weeks
    2) Histologically proven, primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) after treatment(s) including surgery and radiotherapy with or without chemotherapy (according to local practice; Stupp protocol, Stupp et al., 2005) and following discontinuation of any previous standard or investigational lines of therapy
    3) Confirmation that archived tissue is available from first diagnosis of GB for biomarker analysis
    4) Subjects must have evidence of tumor recurrence/progression as determined by standard RANO criteria following standard therapy:
    a) Includes primary GB
    b) Screening MRI must be performed within 14 days prior to planned infusion, and subjects receiving steroids must be on a stable, or decreasing dose for at least 5 days prior to imaging
    c) More than 12 weeks must have elapsed since the completion of radiation therapy at the time of study entry, unless the majority of the new enhancement is outside of the radiation field (for example, beyond the high-dose region or 80% isodose line)
    5) Recurrent tumor must be supratentorial, contrast-enhancing GB no smaller than 1 cm x 1 cm (largest perpendicular dimensions) and no larger than 4 cm maximum in a single direction based on MRI taken within 14 days prior to catheter placement
    6) Karnofsky Performance Score (KPS) ≥ 70
    7) Women of child-bearing potential must have a negative beta-human chorionic gonadotropin pregnancy test documented within 14 days prior to treatment
    8) Women and men of child-bearing potential must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence, etc. for the duration of study participation and for 6 months post drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately,
    9) Requirements for organ and marrow function as follows:
    • adequate bone marrow function:
    o leukocytes > 2,000/μL
    o absolute neutrophil count > 1,000/μL
    o platelets > 100,000/μL
    • adequate hepatic function:
    o total bilirubin < 1.5 X institutional upper limit of normal (ULN)
    o aspartate transaminase (AST) < 2.5 X institutional upper limit of normal (ULN)
    o alanine transaminase (ALT) < 2.5 X institutional ULN
    • adequate renal function:
    o creatinine not to exceed 1.5 X institutional ULN
    OR
    o creatinine clearance: ≥ 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional ULN
    • lymphocytes > 500/μL
    • adequate coagulation function
    o international normalized ratio (INR) < 1.4
    o partial thromboplastin time (PTT) ≤ institutional ULN, unless receiving therapeutic low molecular weight heparin (corrected, if necessary, to exclude potential antibody effects)
    10) Able to read, understand, and sign the informed consent document before undergoing any study-specific procedures or have a legal representative willing to do so; subjects must be registered prior to treatment with study drug
    11) Subjects must be able and willing to undergo multiple brain MRI examinations
    12) Subjects must be able and willing to comply with all study procedures
    13) Any related toxicities following discontinuation of prior GB therapies must have resolved to CTCAE Grade 1 or lower prior to inclusion in this study
    E.4Principal exclusion criteria
    1) Prior treatment with cytotoxic chemotherapy
    a) Temozolomide (standard induction and / or maintenance dosing) within the past 4 weeks prior to planned infusion
    b) “Metronomic” Temozolomide (low-dose, continuous administration) within the past 7 days prior to planned infusion
    c) Nitrosoureas within the past 6 weeks prior to planned infusion
    d) Treatment with any other cytotoxic agent within the past 4 weeks prior to planned infusion
    2) Prior investigational treatment within the past 4 weeks or prior immunotherapy or antibody therapy within the past 4 weeks prior to planned infusion; Subjects with prior immunotherapy within 6 months of planned infusion must have confirmed evidence of tumor recurrence/progression as determined by iRANO or mRANO criteria.
    3) Prior treatment with bevacizumab (Avastin) or other vascular-endothelial growth factor (VEGF) inhibitors or VEGF-receptor signaling inhibitors within the past 4 weeks prior to planned infusion
    4) Prior therapy that included interstitial brachytherapy or Gliadel® Wafers (carmustine implants) within the past 12 weeks prior to planned infusion
    5) Prior surgery (including stereotactic radiosurgery and biopsy procedures) within the past 4 weeks prior to planned of infusion
    6) Ongoing Optune© therapy within 5 days of planned initiation of infusion
    7) Secondary GB (i.e., GB that progressed from low-grade diffuse astrocytoma or AA)
    8) Known mutation in either the isocitrate dehydrogenase 1 (IDH1) or the IDH2 gene.
    9) Tumor in the brainstem (not including fluid-attenuated inversion recovery [FLAIR] changes), an infratentorial tumor, diagnosis of gliomatosis cerebri (highly infiltrative T2 hyperintense tumor with ill-defined margins encompassing at least three lobes of the brain.
    10) Multifocal or multicentric satellite tumors with enhancement observed outside a 4cm x 4cm area on a single plane (maximum area covered by drug infusion). Multifocal lesions are defined by >1 measurable enhancing lesion (1cm x 1cm perpendicular dimensions) separated by at least 1cm with confluent T2 hyperintensity between the lesions. Multicentric lesions are defined by >1 measurable enhancing lesion (1cm x 1cm perpendicular dimensions) separated by at least 1cm with normal brain between the lesions). Measurable enhancing tumors separated by at least 1cm with any enhancing components >4cm apart are excluded from the current study, as these regions will not be covered by the infusion.
    11) Tumor with a mass effect (e.g. 1 cm midline shift)
    12) Subjects with tumors for which the preponderance of tissue is not of the type in which convection would be possible (e.g. preponderance of cystic component)
    13) Tumor with geometric features that make them difficult to adequately cover the tumor volume with infusate by using CED catheters; 14) Clinical symptoms that are thought by the Investigator to be caused by uncontrolled increased intracranial pressure, hemorrhage, or edema of the brain
    15) Any condition that precludes the administration of anesthesia
    16) Known to be human immunodeficiency virus positive
    17) On-going treatment with cytotoxic therapy; no additional antineoplastic therapies (including surgical modalities) are planned until there is confirmed evidence of tumor progression (as per modified RANO criteria) after administration of the study drug
    18) Concurrent or a history of any significant medical illnesses that in the Investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the subject’s ability to tolerate the study drug therapy and/or put the subject at additional risk or interfere with the interpretation of the results of this trial
    19) Known history of allergy to gadolinium contrast agents
    20) Presence of another type of malignancy requiring treatment within < 3 years prior to the screening visit, except for adequately treated carcinoma in-situ of the cervix, prostate cancer not actively treated, and basal or squamous cell carcinoma of the skin
    21) Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition that is likely to affect the subject’s returning to the investigational site for follow-up visits including for imaging or other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject’s enrollment incompatible with study objectives
    E.5 End points
    E.5.1Primary end point(s)
    ORR as determined by an independent central review (Imaging Core Lab) according to modified RANO criteria, as assessed by gadolinium-enhanced MRI approximately 30, 60, 90, 120, 180, 240, and 360 days post-CED infusion relative to pre-treatment baseline MRI (acquired for treatment planning prior to catheter placement).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment by gadolinium-enhanced MRI approximately 30, 60, 90, 120, 180, 240, and 360 days post-CED infusion relative to pre-treatment baseline MRI
    E.5.2Secondary end point(s)
    1.OS, defined as the time from treatment until death.
    2.PFS, defined as the time from treatment until disease progression (per modified RANO criteria and as determined by an independent central review) or death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After progression (on study or during follow-up), subjects will continue to be followed for survival and post-study treatment for GB until death (or termination of data collection by the Sponsor or withdrawal of consent by the subject).
    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 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 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 States
    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
    LFVLS
    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 months7
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial months21
    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: 43
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 43
    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)
    Standard of care
    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 Decision2017-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-24
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