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    Summary
    EudraCT Number:2012-004240-30
    Sponsor's Protocol Code Number:AIT-MULTIVIR-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-12-02
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2012-004240-30
    A.3Full title of the trial
    Prospective, open-label, randomised, two-arm, controlled, multicentre clinical trial, phase I/IIa, for the evaluation of safety and efficacy of an adoptive immunotherapy with allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for the prevention or treatment of reactivation of 'CMV and/or EBV in patients after allogeneic HLA-identical stem cell transplantation
    Prospektive, offene, randomisierte, zweiarmige, kontrollierte, multizentrische klinische Prüfung der Phase I/IIa zur Evaluation der Sicherheit und Wirksamkeit einer adoptiven Immuntherapie mit allogenen CMV-/EBV-spezifischen peptidstimulierten T-Zellen (CD3+) zur Verhinderung (präventiv) oder Behandlung (präemptiv) der Reaktivierung von CMV und/oder EBV bei Patienten nach allogener HLA-identer Stammzelltransplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective clinical trial for the evaluation of safety and efficacy of virus-specific T-cells for the prevention or treatment of cytomegaly or Epstein-Barr virus infection in patients after allogeneic stem cell transplantation. The treatment will be compared to standard treatment. The allocation to treatment arms is done randomly. The trial will be conducted at several study sites.
    Prospektive klinische Prüfung zur Überprüfung der Sicherheit und Wirksamkeit von virusspezifischen T-Zellen zur Verhinderung oder Behandlung einer Cytomegalie- oder Epstein-Barr-Infektion in Patienten nach allogener Stammzelltransplantation. Die Behandlung wird mit der Standardtherapie verglichen. Die Zuteilung zu den Behandlungsgruppen erfolgt nach dem Zufallsprinzip. Die Prüfung wird an mehreren Prüfstellen durchgeführt.
    A.3.2Name or abbreviated title of the trial where available
    MULTIVIR01
    A.4.1Sponsor's protocol code numberAIT-MULTIVIR-01
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportBayerisches Staatsministerium für Bildung und Kultus, Wissenschaft und Kunst
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Campus Virchow-Klinikum
    B.5.2Functional name of contact pointMedizinische Klinik Hämatologie
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number+49030450 565256
    B.5.5Fax number+49030450 553914
    B.5.6E-mailarmin.gerbitz@charite.de
    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.2.1.1.1Trade name N.A.
    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 nameAllogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+) solution for injection
    D.3.2Product code N.A.
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Immune deficiency after allogeneic stem cell transplantation
    Immunschwäche nach allogener Stammzelltransplantation
    E.1.1.1Medical condition in easily understood language
    Weakness of the immune system after allogeneic stem cell transplantation
    Abwehrschwäche nach allogener Stammzelltransplanation
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10007877
    E.1.2Term Cell-mediated immune deficiency
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the safety and tolerability of an adoptive immunotherapy with CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for prevention or treatment of the reactivation of CMV or EBV infection in patients after allogeneic HLA-identical stem cell transplantation.
    Evaluation der Sicherheit und Verträglichkeit einer adoptiven Immuntherapie mit CMV-/EBV-spezifischen peptidstimulierten T-Zellen (CD3+) zur Verhinderung (präventiv) oder Behandlung (präemptiv) der Reaktivierung von CMV und/oder EBV bei Patienten nach allogener HLA-identer Stammzelltransplantation.
    E.2.2Secondary objectives of the trial
    • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the occurrence of CMV and/or EBV reactivation in patients after allogeneic stem cell transplantation.
    • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the utilisation of anti-CMV medication (ganciclovir, valganciclovir, foscavir, cidofovir).
    • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the utilisation of rituximab after EBV reactivation.
    • Impact of a preventive/preemptive adoptive immunotherapy with CMV-/EBV-specific T-cells on the reconstitution of the T-cell compartment.
    • Einfluss einer präventiven/präemptiven adoptiven Immuntherapie mit CMV-/EBV-spezifischen T-Zellen auf das Auftreten einer Reaktivierung von CMV und/oder EBV bei Patienten nach allogener Stammzelltransplantation.
    • Einfluss einer präventiven/präemptiven adoptiven Immuntherapie mit CMV-/EBV-spezifischen T-Zellen auf den Verbrauch antiviral wirksamer Medikamente gegen CMV (Ganciclovir, Valganciclovir, Foscavir, Cidofovir).
    • Einfluss einer präventiven/präemptiven adoptiven Immuntherapie mit CMV-/EBV-spezifischen T-Zellen auf den Verbrauch von Rituximab bei EBV-Reaktivierung.
    • Einfluss einer präventiven/präemptiven adoptiven Immuntherapie mit CMV-/EBV-spezifischen T-Zellen auf die Rekonstitution des T-Zellkompartiments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female person of 18 to 75 years of age
    • Unlimited ability to provide informed consent
    • Written informed consent
    • Indication for allogeneic stem cell transplantation
    • HLA-identical donor, related or unrelated, HLA match: 10/10
    • Stem cell source: G-CSF mobilised peripheral blood stem cells
    • Positive EBV serology of the donor
    • Positive CMV serology of the donor
    • Effective contraception for females of child-bearing potential
    • Männliche oder weibliche Person im Alter von 18 bis 75 Jahre
    • Vorliegen der uneingeschränkten Einwilligungsfähigkeit
    • Vorliegen der schriftlichen Einwilligung
    • Indikation zur allogenen Stammzelltransplantation
    • HLA-identer Spender, verwandt oder unverwandt, HLA-Match: 10/10
    • Stammzellquelle: G-CSF mobilisierte periphere Blutstammzellen
    • Positive EBV-Serologie des Spenders
    • Positive CMV-Serologie des Spenders
    • Effektive Kontrazeption bei Frauen im gebärfähigen Alter
    E.4Principal exclusion criteria
    • Donor seronegative for EBV
    • Donor seronegative for CMV
    • Bone marrow or umbilical blood as stem cell source
    • Alemtuzumab (Campath®) for conditioning
    • Sorror score >3
    • Known hypersensitivity to one of the ingredients of the IMP
    • Pregnant or breast-feeding female
    • Spender EBV-seronegativ
    • Spender CMV-seronegativ
    • Knochenmark oder Nabelschnurblut als Stammzellquelle
    • Alemtuzumab (Campath®) zur Konditionierung
    • Sorror-Score >3
    • Bekannte Überempfindlichkeit gegenüber einem der Inhaltsstoffe des Prüfpräparats
    • Schwangere oder stillende Frau
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety endpoints:
    Occurrence of acute toxicity, such as an allergic or anaphylactic reaction ( CTCAE Grade ≥2 ) , within 72 hours after administration of the IMP
    • De novo onset of acute GVHD within 14 days after administration of the IMP. Criteria : Staging and grading according to Glucksberg
    • occurrence of an aggravation of pre-existing acute GvHD (persistent acute GvHD ) within 14 days after administration of the IMP. Criteria: Staging and grading according to Glucksberg
    Primäre Sicherheitsendpunkte sind
    • Auftreten einer Akuttoxizität i.S. einer allergischen oder anaphylaktischen Reaktion (CTCAE Grad ≥2), innerhalb von 72 Stunden nach Applikation des Prüfpräparates
    • De novo Auftreten einer akuten GvHD innerhalb von 14 Tagen nach Applikation des Prüfpräparates. Kriterien: Stadieneinteilung und Graduierung nach Glucksberg
    • Auftreten einer Verschlechterung einer vorbestehenden akuten GvHD (persistierende akute GvHD) innerhalb von 14 Tagen nach Applikation des Prüfpräparates. Kriterien: Stadieneinteilung und Graduierung nach Glucksberg
    E.5.1.1Timepoint(s) of evaluation of this end point
    At all visits during the observation period
    Zu allen Visitenzeitpunkten im Beobachtungszeitraum
    E.5.2Secondary end point(s)
    Occurrence of at least one CMV reactivation during the observation period
    • Occurrence of at least one EBV reactivation during the observation period
    • Occurrence of CMV viral load requiring treatment within the observation period
    • Occurence of EBV viral load requiring treatment within the observation period
    • Quantitative detection of EBV-specific T- cells at the time 204 ± 7 days after SZT
    • Quantitative detection of CMV-specific T cells at the time of 204 ± 7 days after SZT
    • Consumption of Antivirals ganciclovir / valganciclovir / foscavir / cidofovir within the observation period
    • Consumption of rituximab in EBV reactivation within the observation period
    • Auftreten mindestens einer CMV-Reaktivierung im Beobachtungszeitraum
    • Auftreten mindestens einer EBV-Reaktivierung im Beobachtungszeitraum
    • Auftreten einer behandlungsbedürftigen CMV-Viruslast im Beobachtungszeitraum
    • Auftreten einer behandlungsbedürftigen EBV-Viruslast im Beobachtungszeitraum
    • Quantitativer Nachweis EBV-spezifischer T-Zellen zum Zeitpunkt 204±7 Tage nach SZT
    • Quantitativer Nachweis CMV-spezifischer T-Zellen zum Zeitpunkt 204±7 Tage nach SZT
    • Verbrauch der Virustatika Ganciclovir/Valganciclovir/Foscavir/Cidofovir im Beobachtungszeitraum
    • Verbrauch an Rituximab bei EBV-Reaktivierung im Beobachtungszeitraum

    E.5.2.1Timepoint(s) of evaluation of this end point
    All during the observation period
    Alle während des Beobachtungszeitraums
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    Standardtherapie
    Standard treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    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
    LVLS
    Letzte Visite des letzten Studienteilnehmers
    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 months3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    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)
    At the discretion of the transplant centre
    Nach Maßgabe des behandelnden Transplantationszentrums
    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 Decision2014-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-26
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