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    Summary
    EudraCT Number:2020-004124-42
    Sponsor's Protocol Code Number:CCRG19-001
    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:2023-01-31
    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 number2020-004124-42
    A.3Full title of the trial
    First-in-human interleukin-15-transpresenting Wilms’ tumor protein 1-targeting autologous dendritic cell vaccination in cancer patients
    First-in-human studie met interleukine-15-transpresenterende Wilms' tumor 1-gerichte autologe dendritische celvaccins in kankerpatiënten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and feasibility evaluation of a new dendritic cell vaccine as immunotherapy for cancer patients

    Veiligheids- en haalbaarheidsevaluatie van een nieuw dendritisch celvaccin als immuuntherapie in kankerpatiënten
    A.3.2Name or abbreviated title of the trial where available
    IL15 TransDC
    A.4.1Sponsor's protocol code numberCCRG19-001
    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 Hopsital
    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 tegen Kanker
    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 nameIL15-transpresenting WT1-targeted Dendritic cells
    D.3.2Product code WT1/IL15/IL15Ra mRNA 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 INNWT1/IL15/IL15Ra mRNA DC
    D.3.9.2Current sponsor codeWT1/IL15/IL15Ra mRNA DC
    D.3.9.3Other descriptive nameAutologous dendritic cells electroporated with mRNA encoding WT1, IL15 and IL15 receptor alpha subunit
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number90000000 to 1000000000
    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
    histologically or cytologically confirmed solid tumor of the pancreas, esophagus, liver or ovaries that is advanced, recurrent or progressing after at least first-line anti-cancer treatment, or for which no alternative standard therapy is available due to intolerance to or refusal of standard-of-care treatment.
    Histologisch of cytologisch bevestigde solide tumor van de pancreas, slokdarm, lever of eierstokken die vergevorderd of terugkerend of progressief is na tenminste een eerstelijns kankerbehandeling, of waarvoor er geen alternatieve standaardtherapie beschikbaar is omwille van intolerantie of weigering van de standaardbehandeling
    E.1.1.1Medical condition in easily understood language
    Advanced or refractory solid tumors of the pancreas, esophagus, liver or ovaries.
    Vergevorderde of terugkerende solide tumoren van de pancreas, slokdarm, lever of eierstokken.
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10070308
    E.1.2Term Refractory cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the feasibility and safety of IL-15-transpresenting WT1-targeted DC vaccine production and administration in patients with advanced or refractory solid tumors.
    E.2.2Secondary objectives of the trial
    - To assess indicators of clinical efficacy of vaccination with IL-15-transpresenting WT1-targeting DCs in patients with advanced or refractory solid tumors
    - To determine the in vivo immunogenicity of IL-15-transpresenting WT1-targeting DC vaccination in patients with advanced or refractory solid tumors
    - To document and characterize changes in general and disease-specific quality of life using EQ-5D-5L and QLQ-C30 questionnaires at predefined time points.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis with a histologically or cytologically confirmed solid tumor of the pancreas, esophagus, liver or ovaries that is advanced, or recurrent or progressing after at least first-line anti-cancer treatment, or for which no alternative standard therapy is available due to intolerance to or refusal of standard-of-care treatment.
    - At least 1 measurable or evaluable lesion as defined by the latest version of Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
    - Reasonable life expectancy of at least 3 months (in the Investigator’s opinion)
    - Aged ≥ 18 years at the time of signing informed consent
    - World Health Organization (WHO) performance status 0-2
    - Adequate hematologic and end-organ function
    E.4Principal exclusion criteria
    - Use of any investigational agent within 4 weeks before the planned day of leukapheresis
    - Active or history of autoimmune disease or immune deficiency
    - Pregnancy or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    (i) Feasibility
    - proportion of patients that had a successful leukapheresis
    - proportion of patients that had successful vaccine production and meeting all quality control measurements
    - proportion of patients who complete the study treatment schedule within the timeline schedule proposed in the study protocol

    (ii) Safety
    Occurrence of AEs and SAEs during IL-15-transpresenting WT1-targeting DC vaccine administration and during follow-up
    - Proportions of patients in the safety population that experienced AEs, SAEs possibly, probably or definitely related to IL-15-transpresenting WT1-targeting DC vaccination
    - Number and grade of AEs and SAEs in the safety population
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety evaluation for proceeding into an expansion cohort will be done as soon as possible after the safety-limiting adverse event (SLAE) reporting period of the last included patient of the safety cohort has ended (i.e. 24 hours post V6) and will be based on the occurrence of SLAEs, according to a best of five design.

    At the end of study (i.e. 90 days after final IL-15-transpresenting WT1-targeting DC vaccine administration of the last included patient), data for feasibility and safety will be evaluated.
    E.5.2Secondary end point(s)
    (i) Clinical efficacy
    - best overall response
    - the duration of response for patients with OR
    - overall response rate
    - disease control rate
    - progression-free survival
    - overal survival

    (ii) immunogenicity, including but not restricted to:
    - functional WT1-specific T cell responses

    (iii) quality of life
    - how patients experience the study therapy,
    - how patient-reported disease-related symptoms evolve over time
    - how patient-reported quality of life evolves over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of study (i.e. 90 days after final IL-15-transpresenting WT1-targeting DC vaccine administration of the last included patient), data for clinical efficacy, immunogenicity and quality of life 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 Yes
    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 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 is defined as the date when all evaluable patients have reached 90 days after final IL-15-transpresenting WT1-targeting DC vaccine administration (V6)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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.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 treatment and follow-up
    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 Decision2023-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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