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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2020-004125-23
    Sponsor's Protocol Code Number:CCRG19-002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-23
    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 number2020-004125-23
    A.3Full title of the trial
    Adjuvant dendritic cell immunotherapy complementing conventional therapy for pediatric patients with high-grade glioma and diffuse intrinsic pontine glioma
    Adjuvante immuuntherapie met dendritische cellen ter aanvulling van conventionele therapieën voor pediatrische patiënten met hooggradige gliomen en diffuse intrinsieke gliomen van de pons
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalized dendritic cell-based immune therapy for improving treatment of children with brain (stem) tumors
    Gepersonaliseerde dendritische cel-gebaseerde immuuntherapie ter verbetering van de behandeling voor kinderen en jongeren met hersen- en hersenstamtumoren
    A.3.2Name or abbreviated title of the trial where available
    ADDICT-pedGLIO
    A.4.1Sponsor's protocol code numberCCRG19-002
    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 SponsorAntwerp University Hospital
    B.1.3.4CountryBelgium
    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 supportKom op tegen Kanker
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportStichting Semmy
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportOlivia Fund
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntwerp University Hospital
    B.5.2Functional name of contact pointCCRG
    B.5.3 Address:
    B.5.3.1Street AddressDrie Eikenstraat 655
    B.5.3.2Town/ cityEdegem
    B.5.3.3Post code2650
    B.5.3.4CountryBelgium
    B.5.4Telephone number003238213928
    B.5.5Fax number003238214456
    B.5.6E-mailccrg@uza.be
    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 namecryopreserved Wilms' tumor 1 (WT1) mRNA-electroporated dendritic cells
    D.3.2Product code WT1 EP DC
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWilms' tumor 1 (WT1) mRNA-electroporated dendritic cells
    D.3.9.2Current sponsor codeWT1 EP DC
    D.3.9.3Other descriptive nameAUTOLOGOUS WT1 RNA LOADED DENDRITIC CELLS
    D.3.9.4EV Substance CodeSUB181359
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number90.10e6 to 1000.10e6
    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 Yes
    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 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
    Childhood high-grade glioma and diffuse intrinsic pontine glioma
    hooggradige gliomen en diffuse intrinsieke gliomen van de pons bij kinderen
    E.1.1.1Medical condition in easily understood language
    Children and adolescents with brain (stem) tumors
    Kinderen en jongeren met hersen- en hersenstamtumoren
    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 LLT
    E.1.2Classification code 10046859
    E.1.2Term Vaccination
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006143
    E.1.2Term Brain stem glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080666
    E.1.2Term Diffuse intrinsic pontine glioma
    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 evaluate the feasibility of WT1-targeted DC vaccine production and administration in pediatric patients with HGG and DIPG, either in combination with first-line chemoradiation treatment or as adjuvant therapy following previous therapies, and to investigate the resulting safety profile.
    E.2.2Secondary objectives of the trial
    - To assess indicators of clinical activity of vaccination with WT1-targeted DC in pediatric patients with HGG and DIPG
    - To determine the in vivo immunogenicity of WT1-targeted DC vaccinations in pediatric patients with HGG and DIPG
    - To document and characterize changes in patient- and proxy-reported general and disease-specific quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of HGG (WHO grade III or IV, histologically verified) or DIPG (verified by radiologic criteria (magnetic resonance imaging (MRI)) or by histology. A biopsy is not required but recommended.)
    - Aged ≥ 12 months and < 18 years at the time of signing the informed consent
    - Body weight ≥ 10 kg
    - Lansky score (for patients < 16 years) or Karnofsky score (for patients ≥ 16 years) of ≥ 50
    - Reasonable life expectancy ≥ 8 weeks, as estimated by the treating physician
    - Adequate hematological blood values and sufficient recovery from treatment-related toxicities (> grade 1) following previous anti-glioma treatments, as judged by the treating physician (applies to stratum B only).
    - Written informed consent of parents or legal guardian and of patients aged 12 years or older. Written informed consent of patients younger than 12 years is optional.
    - Willing and able to comply with the protocol, as judged by the treating physician
    - Female patients of child bearing potential must have a negative serum or urine pregnancy test at the time of screening. Female patients of child bearing potential and male patients must agree to use effective contraception before, during and for at least hundred days after the last study treatment administration. Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until at least hundred days after the last study treatment administration.
    E.4Principal exclusion criteria
    - Use of any investigational agents ≤ 4 weeks before the planned day of leukapheresis.
    - Concomitant malignancy or history of another malignancy (unless the Investigator rationalizes otherwise)
    - Known concomitant presence of any active immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
    - Any pre-existing contra-indication for contrast-enhanced MRI
    - Pregnant or breastfeeding
    - Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications
    E.5 End points
    E.5.1Primary end point(s)
    (i) Feasibility
    - Proportion of patients in the intention-to-treat (ITT) population that had successful leukapheresis
    - Proportion of patients in the ITT population that had successful vaccine production (i.e. production of 9 or more vaccines meeting quality control requirements)
    - Proportion of patients in the ITT population who complete the study treatment schedule (i.e. from leukapheresis until administration of the 9th vaccine)
    - Proportion of efficacy evaluable patients in the ITT population

    (ii) Safety
    Occurrence of AEs and SAEs during DC vaccine administration and follow-up period:
    - Proportion of patients of the safety population that experienced (S)AEs possibly, probably or definitely related to DC vaccination
    - Number and grade of (S)AEs in the safety population

    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of study (i.e. when all patients have reached 90 days after final DC vaccine administration or 24 months after study entry (whichever occurs later)) data for feasibility and safety will be evaluated.
    E.5.2Secondary end point(s)
    (i) Indicators of clinical activity:
    - Best overall response
    - Progression free survival
    - Overall survival

    (ii) Immunogenicity
    The immunogenicity endpoints include, but are not limited to, the following measures of (anti-tumor) immune responses:
    - Functional WT1-specific T cell responses
    - Occurrence of WT1-specific CD8+ T cells
    - Functional WT1-specific T cell responses

    (iii) Quality of life
    - How patients experience different phases of the study treatment schedule
    - How patient- and proxy-reported disease-related symptoms evolve over time during the study
    - How patient- and proxy-reported general quality of life evolves over time during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    At end of study (i.e. when all patients have reached 90 days after final DC vaccine administration or 24 months after study entry (whichever occurs later)) data for clinical activity, immunogenicity and quality of life questionnaires will be evaluated.
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I - safety/feasibility
    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 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 will occur when all enrolled patients have reached 90 days of follow-up after final DC vaccine administration or 24 months after study entry, whichever occurs later. Based on the anticipated accrual period of 36 months, the study is estimated to last approximately 72 months.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged ≥ 12 months and < 12 years.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Normal follow up and treatment.
    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 Decision2021-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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