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    Summary
    EudraCT Number:2013-002492-17
    Sponsor's Protocol Code Number:VISIT-V2
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-03
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-002492-17
    A.3Full title of the trial
    Treatment of adenovirus and cytomegalovirus infection post human allogeneic stem cell transplantation with short-term expanded virus-specific T cells
    Behandlung von Adeno- und Cytomegalie-Virusinfektionen nach allogener Stammzelltransplantation mit in vitro short-term expandierten virusspezifischen T Zellen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    virus-specific immunotherapy
    virus spezifische Immuntherapie
    A.3.2Name or abbreviated title of the trial where available
    VIsIT
    A.4.1Sponsor's protocol code numberVISIT-V2
    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 SponsorSt. Anna Kinderkrebsforschung
    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 supportSt Anna Kinderkrebsforschung
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportCIT Vienna
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportKapsch Grant
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSIRP
    B.5.2Functional name of contact pointRuth Ladenstein
    B.5.3 Address:
    B.5.3.1Street AddressZimmermannplatz 10
    B.5.3.2Town/ cityVienna
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404704750
    B.5.5Fax number00431404707430
    B.5.6E-mailruth.ladenstein@stanna.at
    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 namevirus specific T cells
    D.3.4Pharmaceutical form Concentrate 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.3.9.3Other descriptive nameVIRUS SPECIFIC T-CELLS
    D.3.9.4EV Substance CodeSUB96123
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,5x10E3CD3+ to 5x10E3CD3+
    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) 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 undergoing allogeneic HSCT undergo weekly screening for HAdV and CMV PCR. In case of viraemia ≥ 100 copies/ml PB preemptive antiviral with either Gancyclovir or Cidofovir conform to the local HSCT-infection-SOPs. In case of increasing viral load despite adequte virostatic treatment for two weeks, the administration of donor derived (or receipient derived in case of donor CMV negativity and receipient positivity before HSCT) virus specific T cells is foreseen
    Patienten nach allogener Stammzelltransplantation werden wöchentlich auf CMV und ADV gescreent und erhalten bei Virämie die entsprechende virostatische Therapie. in einigen Fällen ist die Virusinfektion trotz adäquater virostatischer Therapie progredient. In diesem Fall ist eine zusätzliche Therapie mit Virus-spezifischen Spender-T-zellen (bzw. Virus-spezifischen autologen T-Zellen, wenn vor HSCT beim Empfänger vorhanden) vorgesehen.
    E.1.1.1Medical condition in easily understood language
    patients after allogeneic HSCT with increasing viral load inspite of virostatic treatment for two weeks may reiceive virus-specific T cells
    Patienten nach allogener Stammzelltransplantation mit steigender Viruslast trotz virostatischer Behandlung für zwei Wochen können virus-spezifische T-Zellen erhalten
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10050541
    E.1.2Term Cytomegalovirus antigen positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Primary:

    Evaluation of feasibility, safety and potential side effects of short-term expanded HAdV- and CMV-specific T- cells (seVirus-T-cells) in patients with HAdV and/or CMV viraemia not responding to antiviral therapy after allogeneic HSCT.
    • Acute toxicity (Grade III-IV) of seVirus-T-cell infusion within 48 hours from infusion

    • De novo acute GvHD > Gr II or increase of pre-existing GvHD more than 1 grade from 2 weeks post infusion until 8 weeks post infusion
    • incidence of graft rejection
    Erfassung der Verträglichkeit bzw. Inzidenz der akut-Toxizität, der akuten GvHD Gr III-IV und der Graft-Abstoßung nach der Gabe von Virus-spezifischen-T-Zellen
    E.2.2Secondary objectives of the trial
    2. Secondary:

    Detection of virus-specific T-cells within 8 weeks after T-cell therapy. Measurement of the viral load following the infusion of seVirus-T-cells

    Correlation of the presence of virus-specific T-cells with partial reduction (>1 log viral copies /ml blood)
    or complete clearance of viral load.

    Tracking of the infused seVirus-T-cells by NGS of the TCRs
    Detektion von virus-spezifischen T-Zellen innerhalb von 8 Wochen nach verabreichter Zelltherapie. Messung der Viruslast nach verabreichter Se-Virus-T-Zell Infusion.

    Korrelation der vorhandenen e-Virus-T-Zellen mit der Reduktion oder Beseitigung der Viruslast.

    Tracking der infundierten e-Virus-T-Zellen via NGS des TCR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children and adolescents (0-18 years) who undergo any type of allogeneic stem cell transplantation at the St Anna Children`s Hospital, Vienna.
    • Informed consent is signed
    • Presence of HAdV or CMV-specific T-cells in the donor or CMV-specific T-cells in the recipient pre-transplant
    • Stable (≥ 10E6) or increasing viraemia despite antiviral treatment post HSCT
    • Absence of virus-specific T cells post transplant
    • Karnofsky / Lansky score >50%
    • Pregnancy excluded
    Kinder und Jugendliche (0-18 Jahre) nach allogener Stammzelltransplantation
    • Informed consent unterschrieben
    • Vorhandensein von HAdV oder CMV-spezifischen T-Zellen im Spender bzw. CMV-spezifische T-Zellen im Empfänger vor HSCT
    • Konstanz (≥ 10E6) oder Zunahme der Virämie trotz adäquater virostatischer Therapie über 2 Wochen
    • kein Nachweis von Virus-spezifischen Zellen im Patienten
    • Karnofsky / Lansky score >50%
    • Schwangerschaft ausgeschlossen
    E.4Principal exclusion criteria
    • Infusion of polyclonal or monoclonal T-cell directed antibodies within 28 days before seVirus T-Cell infusion
    • Multiple organ failure at screening-timepoint seVirus T-Cell infusion
    • History of GvHD Gr III-IV or actual GvHD Gr III-IV
    • Pregnancy
    • Treatment with granulocyte transfusion within the last 72 hours
    • Karnofsky / Lansky score <50%
    • Subject is unwilling or unable to comply with the study procedures
    • High dose treatment with steroids (≥ 2mg/kg/d, methylprednisone-equivalent)
    - keine Infusion von monoklonalen oder polyclinalen T-Zell Antikörpern innerhalb der vorangegangenen 28 Tage
    - kein Multiorganversagen
    - keine vergangene oder aktuelle GvHD Gr III-IV
    - Schwangerschaft
    - keine Transfusion von Granulozytenkonzentraten innerhalb der vorangegangenen 72 Stunden
    - Karnofsky / Lansky score <50%
    - Patient ist unwillig oder nicht in der Lage, sich in den Studienablauf einzugliedern
    - Hochdosis-Behandlung mit Steroiden (≥ 2mg/kg/d, methylprednisone-equivalent)
    E.5 End points
    E.5.1Primary end point(s)
    • Non pre-existing Immune System Disorders i.e. Allergic reaction, Anaphylaxis, Cytokine release syn-drome or Serum sickness of Grade III-IV) of seVirus-T-cell infusion within 48 hours from infusion
    • De novo acute GvHD > Gr II or increase of pre-existing GvHD more than 1 grade from 2 weeks post infusion until 8 weeks post infusion
    • Incidence of graft rejection (within 8 weeks)
    1. akute Unverträglichkeitsreaktion innerhalb von 48 Stunden nach Infusion
    2. akute GvHD Grad III-IV innerhalb von 8 Wochen nach Infusion
    3. Inzidenz der Graft-Abstoßung
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.: 48 hours after infusion
    2. and 3.: 8 weeks after infusion
    1.: 48 Stunden nach Infusion
    2. und 3.: 8 Wochen nach Infusion
    E.5.2Secondary end point(s)
    1. Detection of virus-specific T-cells within 8 weeks after T-cell therapy. Measurement of the viral load following the infusion of seVirus-T-cells
    2. Correlation of the presence of virus-specific T-cells with partial reduction (>1 log viral copies /ml blood) or complete clearance of viral load.
    3. Tracking of the infused T-cells by NGS of the TCRs.
    1. Nachweis von Virus-spezifischen T-Zellen im Patienten innerhalb von 8 Wochen nach der T-Zell-Therapie
    2. Korrelation vorhandene virus-spezifische T-Zellen mit der teilweisen oder vollständigen Reduktion der Virus-Last
    3. Tracking der infundierten T-Zellen via NGS der TCRs
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after infusion
    bis 6 Monate nach Infusion
    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) No
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    last visit of the last subject undergoing this treatment
    Letzter Untersuchungszeitpunkt (6 Monate nach Infusion) des letzten Studienpatienten.
    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 months
    E.8.9.1In the Member State concerned days
    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: 30
    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: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    routine post transplant monitoring and treatment according to the local protocol
    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 Decision2016-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-01
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