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    Summary
    EudraCT Number:2012-002685-12
    Sponsor's Protocol Code Number:Treg002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-10-29
    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 ConcernedGermany - PEI
    A.2EudraCT number2012-002685-12
    A.3Full title of the trial
    Treatment of steroid resistant severe acute gastrointestinal graft-versus-host disease with in vitro expanded donor-derived regulatory T cells
    A prospective open-label one-armed non-randomized multicenter early phase II proof of principle study
    Therapie der Steroid-refraktären gastrointestinalen Graft-versus-Host-Erkrankung mit regulatorischen Spender-T-Zellen (Treg Therapie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of severe gastrointestinal graft-versus-host disease with regulatory T cells
    Therapie der Steroid-refraktären gastrointestinalen Graft-versus-Host-Erkrankung mit regulatorischen Spender-T-Zellen (Treg Therapie)
    A.3.2Name or abbreviated title of the trial where available
    Treg Therapy
    Treg Therapie
    A.4.1Sponsor's protocol code numberTreg002
    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 SponsorUniversity Hospital Regensburg
    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 Immuntherapie Netzwerk (BayImmuNet)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversity Hospital Regensburg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Regensburg
    B.5.2Functional name of contact pointClinical Trial Coordination
    B.5.3 Address:
    B.5.3.1Street AddressFranz-Josef-Strauß-Alle 11
    B.5.3.2Town/ cityRegensburg
    B.5.3.3Post code93053
    B.5.3.4CountryGermany
    B.5.4Telephone number00499419445149
    B.5.5Fax number00499419445148
    B.5.6E-mailpavla.schlosser@ukr.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.2.5The 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.3.2Product code Expanded Tregs
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNexpanded Treg
    D.3.9.3Other descriptive nameexpanded Treg
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 3
    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) 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
    Steroid resistant severe acute gastrointestinal graft-versus-host disease
    Steroid-refraktäre akute gastrointestinale Graft-versus-Host-Erkrankung
    E.1.1.1Medical condition in easily understood language
    graft-versus-host disease
    .
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068908
    E.1.2Term AGVHD
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine whether the transfusion of in vitro expanded donor regulatory T cells improves severe gastrointestinal acute GVHD
    .
    E.2.2Secondary objectives of the trial
    Secondary objectives :
    To determine
    - overall survival and non-relapse mortality at 6 months after Treg cell therapy
    - the influence of Treg cell therapy on other sites of GVHD manifestation than the gastrointestinal tract
    - the impact of Treg cell transfusion on reactivated viruses, de novo virus reactivation or infection and the occurrence of other life-threatening (°IV WHO) infections
    - the frequency of Treg cells in peripheral blood of patients before and at serial time points after Treg treatment

    .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histology-proven GVHD
    - Clinical stage 2-4 acute gastrointestinal GVHD with or without other GVHD manifestations (overall GVHD grade III-IV)
    - Disease resistance to steroid treatment (at least 1 mg/kg bw) - Male and female patients, age 18 - 70y
    - Written informed consent of patient
    - Unterschriebene und datierte Patienten- und Spender-Einverständniserklärung
    - Männliche und weibliche Patienten im Alter zwischen 18 und 70 Jahren
    - Histologisch gesicherte GvHD
    - Akute gastrointestinale GvHD - Grad II bis IV mit oder ohne GVHD-Manifestationen in anderen Organen (Grad III-IV)
    - Steroid-resistente GvHD ( min. 1mg/kg KG)
    E.4Principal exclusion criteria
    - Age <18 y and >70 y
    - No previous steroid therapy (first-line treatment)
    - No previous second-line therapy
    - Severe psychiatric disorders
    - Presumed life expectancy < 4 wks
    - Lack of informed consent
    - Pregnant or nursing woman
    - Patients included in other clinical trials interfering with the present study
    - Donors from outside EU
    - Fehlende Patienten- und Spender-Einverständniserklärung
    - Fehlende Einverständniserklärung der Spender-Datenbank
    - Patienten <18 Jahre und > 70 Jahre
    - Keine vorherige Steroid -First-Line-Therapie
    - schwerwiegenden psychiatrische Krankheit
    - Lebenserwartung unter 4 Wochen
    - Spender außerhalb der EU
    - Einschluss in konkurrierende bzw. überlappende klinische
    Studie
    - Schwangere oder stillende Frauen
    E.5 End points
    E.5.1Primary end point(s)
    Change in gastrointestinal GVHD stage two months after Treg treatment according to modified Glucksberg criteria
    .
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months after therapy.
    .
    E.5.2Secondary end point(s)
    - OS and NRM at 2 and 6 months after Treg treatment
    - Relapse of underlying disease at 6 months after Treg therapy in patients transplanted for heamatologic malignancies
    - GVHD status according to NIH criteria before and at 1, 2 and 6 months after Treg therapy
    - aGVHD activity index before and 1, 2 and 6 months after Treg treatment
    - Quantitative titer for reactivated viruses before and 2, 4 and 8 wks after Treg treatment and de novo virus reactivation or infection
    - De novo °IV infections after Treg therapy according to WHO classification
    - Frequency of Treg cells (defined as CD4+CD25+FOXP3+ by FACS) in peripheral blood at serial time points
    .
    E.5.2.1Timepoint(s) of evaluation of this end point
    .
    .
    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
    early phase II proof of concept
    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 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 concerned5
    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 No
    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
    Trial is terminated after the last study visit of the last subject undergoing the trial.
    .
    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 months6
    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 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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 Yes
    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 state29
    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)
    none
    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 Decision2013-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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