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    Summary
    EudraCT Number:2021-005150-28
    Sponsor's Protocol Code Number:PTC:VS-TC
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-005150-28
    A.3Full title of the trial
    Virus-specific T-cell Immunity for the Treatment of Some Resistant Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation(HSCT)
    Infusione di linfociti T virus-specifici per infezioni virali resistenti alla terapia farmacologica dopo trapianto allogenico di cellule staminali emopoietiche
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT ( VS-TC )
    Linfociti T virus-specifici dopo TCSE allogenico
    A.3.2Name or abbreviated title of the trial where available
    Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT ( VS-TC )
    Linfociti T virus-specifici dopo TCSE allogenico
    A.4.1Sponsor's protocol code numberPTC:VS-TC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05075837
    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 SponsorIRCCS ISTITUTO GIANNINA GASLINI
    B.1.3.4CountryItaly
    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 supportIRCCS Gaslini
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS GASLINI
    B.5.2Functional name of contact pointUOSID Epidemiologia e Biostatistica
    B.5.3 Address:
    B.5.3.1Street AddressVia Gaslini 5
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16147
    B.5.3.4CountryItaly
    B.5.4Telephone number01056363479
    B.5.5Fax number0108981116
    B.5.6E-mailsegreteriastudiclinici@gaslini.org
    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 nameCellule T virus-specifiche
    D.3.2Product code [PTC:VS-TC]
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNCellule T virus-specifiche
    D.3.9.2Current sponsor codePTC:VS-TC
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    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 who have received an allogeneic haematopoietic stem cell transplant and who have developed post-transplant viral reactivation (CMV, Adenovirus, EBV) resistant to pharmacological therapies
    Pazienti che hanno ricevuto un trapianto allogenico di cellule staminali emopoietiche e che hanno sviluppato una riattivazione virale (CMV, Adenovirus, EBV) post trapianto resistente alle terapie farmacologiche
    E.1.1.1Medical condition in easily understood language
    Lymphocytes with antiviral properties administered to patients with cytomegalovirus or Epstein-Barr-Virus or Adenovirus viral infection after hemopoietic stem cell transplantation (HSCT)
    Infezione virale da Citomegalovirus o Epstein-Barr- Virus o Adenovirus in pazienti che hanno subito trapianto allogenico di cellule staminali
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10056559
    E.1.2Term Graft infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT)
    Valutare la sicurezza dell’utilizzo di linfociti-T virus-specifici selezionati in vitro da donatore allogenico (PTC) in pazienti in età tra 0 e 21 anni sottoposti a trapianto allogenico di cellule staminali emopoietiche per il trattamento di infezioni/riattivazioni virali (ADV, EBV, CMV) che abbiano dimostrato resistenza alle terapie farmacologiche disponibili.
    E.2.2Secondary objectives of the trial
    To evaluate the effectiveness of the PTC infusion in controlling the clinical and biological manifestations secondary to the viral infection being treated
    Valutare l’efficacia dell’infusione del PTC nel controllo delle manifestazioni cliniche e biologiche secondarie all’infezione virale oggetto del trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Allogeneic transplant with any cells source and conditioning regimen
    • Age between 0-21 years
    • Viral infection/reactivation (CMV, EBV, ADV)
    • Resistance of viral infections to treatments
    • Absence of concomitant severe uncontrolled infections
    • Life expectancy exceeding 30 days
    • Absence of acute or chronic uncontrolled Graft versus Host Disease
    (GvHD)
    • Absence of acute kidney damage (creatinine value> 3 times the value
    normal with respect to age) not related to viral infection;
    • Absence of severe acute liver injury (direct bilirubin> 3mg / dl or glutamicoxaloacetic
    transaminase -SGOT> 500 UI/L) not related to viral infection;
    • Presence of informed consent to the treatment of the patient / parent /legal
    guardian.
    1. Riceventi in età tra 0 e 21 anni sottoposti a TCSE allogenico. Sono inclusi pazienti trapiantati da qualsiasi tipo di donatore (volontario non correlato [HLA match: 10/10, 9/10, 8/10, 7/10], familiare HLA-identico, familiare HLA mismatch/aploidentico) e con qualsiasi fonte di CSE (midollo osseo, sangue periferico, sangue cordonale) che abbiano raggiunto l’attecchimento dei neutrofili.
    2. Infezioni virali resistenti alle terapie farmacologiche dopo trapianto allogenico di cellule staminali emopoietiche in pazienti pediatrici
    3. Infezione virale dimostrata in biologia molecolare (Real Time qPCR su liquidi biologici o tessuti) da parte di Citomegalovirus (CMV), Epstein-Barr Virus (EBV) o Adenovirus (ADV), con le seguenti caratteristiche per ciascun virus:
    Citomegalovirus: Refrattarietà a due linee di terapia convenzionale (ganciclovir, foscarnet) + una delle seguenti condizioni:
    presenza di coinvolgimento d’organo (insufficienza d’organo attribuita al virus +/- CMV-DNA dimostrato su biopsia);
    numero di copie di virus su plasma superiore a 5000/mmc;
    incremento del numero di copie di virus su plasma di >1 log in determinazioni successive in paziente considerato ad alto rischio (ricevente di trapianto T-depleto oppure donatore di cellule staminali siero-negativo oppure GvHDsteroido-refrattaria trattata con terapia di seconda linea);
    Adenovirus: Refrattarietà ad una linea di terapia convenzionale (cidofovir) + una delle seguenti condizioni:
    presenza di coinvolgimento d’organo (insufficienza d’organo attribuita al virus +/- Adenovirus-DNA dimostrato su biopsia);
    numero di Adenovirus-DNA su plasma >1000/mmc;
    incremento di >1 log del numero di Adenovirus-DNA su plasma in 2 determinazioni successive in paziente considerato ad alto rischio (ricevente di trapianto T-depleto oppure donatore di cellule staminali siero-negativo oppure GvHD in terapia con metilprednisolone> 2mg/kg/die oppure GvHDsteroido-refrattaria in terapia di seconda linea);
    Epstein-Barr virus:
    Tutte le forme di PTLD EBV-correlata (linfoma EBV-correlato) CD20-negative;
    EBV-DNA su plasma >10000 copie/10e5 cellule mononucleate dopo terapia con Rituximab;
    3) Assenza di infezioni severe concomitanti non controllate;
    4) Aspettativa di vita superiore a 30 giorni;
    5) Assenza di GvHD acuta o cronica non controllata;
    6) Assenza di danno renale grave (valore della creatinina > 3 volte il valore normale rispetto all’età) non correlabile all’infezione virale;
    7) Assenza di danno epatico grave (bilirubina diretta >3mg/dl o SGOT>500) non correlabile all’infezione virale;
    8) Presenza di consenso informato al trattamento del paziente/genitore/tutore.
    E.4Principal exclusion criteria
    • Absence of a suitable donor (seronegativity for the virus in question and /
    or failure to respond to the secretion test)
    • Patient with severe renal and/or hepatic impairment as specified above
    • Primary or secondary graft failure
    • Relapse of malignant underlying disease
    1) Assenza di un donatore idoneo (sieronegatività per il virus in oggetto e/o non responsivo al test di secrezione);
    2) Paziente con danno renale e/o epatico grave come sopra specificato; non costituisce criterio di esclusione un’insufficienza renale cronica in dialisi (emodialisi o dialisi peritoneale);
    3) Rigetto primario o secondario;
    4) Paziente in recidiva post-trapianto della malattia oncologica di base.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events
    To collect any adverse event defined as any significant alteration of vital signs and / or organ function, expressed
    in clinical, hematochemical and radiological findings according to version 5 of the Common Terminology Criteria for
    Adverse Events (CTCAE)
    eventi avversi (EA) potenzialmente correlati in al trattamento, definiti come qualsiasi alterazione significativa dei segni vitali e/o della funzionalità d’organo, espressa in termini clinici, ematochimici e radiologici secondo la versione 5 del Common Terminology Criteria for Adverse Events (CTCAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    from day +1 of infusion until day +56
    Dal giorno +1 di infusione al giorno +56
    E.5.2Secondary end point(s)
    Organ damage
    To report any clinical and/or laboratory changes related to the viral infection; Overall survival
    To evaluate the overall survival (OS) after virus-specific T lymphocytes; -Specific cell viral immunity
    To evaluate the specific cell viral immunity for some virus defined as presence and number of CD3 + IFN-gamma +
    lymphocytes count in the patient's peripheral blood; Variation of viremia
    To evaluate viremia variations with the measurement of viral PCR after the infusion of virus-specific T lymphocytes
    evaluated regularly 2 times a week.
    Acquisizione dell’immunità specifica per il virus definita in base alla presenza e al numero di linfociti CD3+IFN-gamma+ virus specifici nel sangue periferico del paziente; Sopravvivenza complessiva a 6 e 12 mesi dall’infusione del PTC; a. manifestazioni cliniche/danno d’organo attribuite all’infezione virale in atto;; viremia valutata in PCR
    E.5.2.1Timepoint(s) of evaluation of this end point
    from day +1 of infusion until day +56; from day +56 to 12 months; from day +1 of infusion until day +56; from day +1 of infusion until day +56
    Dal giorno +1 di infusione al giorno +56; Dal giorno +56 al mese 12; Dal giorno +1 di infusione al giorno +56; Dal giorno +1 di infusione al giorno +56
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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
    cell therapy
    terapia cellulare
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open label
    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 Information not present in EudraCT
    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
    The study will be considered concluded when the last follow-up visit of the last patient is carried out
    Lo studio si riterrà concluso nel momento in cui si effettuerà l'ultima visita di follow-up dell'ultimo paziente
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric patient
    paziente pediatrico
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    Follow-up visits
    Visite di 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 Decision2022-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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