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    Summary
    EudraCT Number:2020-004725-23
    Sponsor's Protocol Code Number:Penta-STs-001
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-15
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-004725-23
    A.3Full title of the trial
    Administration of rapidly generated multipathogen-specific T-Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus fumigatus infections post Allogeneic Stem Cell Transplant
    Χορήγηση ταχέως παραγόμενων, πολυπαθογονο-ειδικών Τ-λεμφοκυττάρων για τη θεραπεία λοιμώξεων από AdV, CMV, EBV, BKV και Aspergillus fumigatus μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    T lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus fumigatus infections after allogeneic stem cell transplantation
    Χορήγηση ταχέως παραγόμενων, πολυπαθογονο-ειδικών Τ-λεμφοκυττάρων για τη θεραπεία λοιμώξεων από AdV, CMV, EBV, BKV και Aspergillus fumigatus μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων
    A.3.2Name or abbreviated title of the trial where available
    Penta-STs-001
    Penta-STs-001
    A.4.1Sponsor's protocol code numberPenta-STs-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 SponsorΓενικό Νοσοκομείο Θεσσαλονίκης "Γεώργιος Παπανικολάου"
    B.1.3.4CountryGreece
    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 supportΓ.Ν.Θ. "Γεώργιος Παπανικολάου"
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationΑιματολογική Κλινική, Μονάδα Μεταμόσχευσης Αιμοποιητικών Κυττάρων, Νοσοκομείο Γ. Παπανικολάου, Θεσσαλονίκη
    B.5.2Functional name of contact pointΓιαννάκη Ευαγγελία
    B.5.3 Address:
    B.5.3.1Street AddressΕξοχή
    B.5.3.2Town/ cityΘεσσαλονίκη
    B.5.3.3Post code57010
    B.5.3.4CountryGreece
    B.5.4Telephone number+302313307518
    B.5.5Fax number+302313307521
    B.5.6E-maileyannaki@u.washington.edu
    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 nameειδικά Τ-λεμφοκυττάρων για τη θεραπεία λοιμώξεων από AdV, CMV, EBV, BKV και Aspergillus fumigatus
    D.3.2Product code Penta-STs-001
    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
    Hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.
    Aσθενείς μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων (HSCT) που παρουσιάζουν λοιμώξεις/ αναζωπυρώσεις των ιών AdV, EBV, CMV και BKV, και του μύκητα Aspergillus fumigatus (AF).
    E.1.1.1Medical condition in easily understood language
    Hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.
    Aσθενείς μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων (HSCT) που παρουσιάζουν λοιμώξεις/ αναζωπυρώσεις των ιών AdV, EBV, CMV και BKV, και του μύκητα Aspergillus fumigatus (AF).
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the feasibility and safety of administering rapidly-generated donor-derived Penta-STs in HSCT recipients with viral or/and fungal reactivation or infection. The second primary objective is to determine the effect of Penta-STs infusion on pathogen load, reconstitution of antiviral and antifungal immunity post-infusion and clinical responses.
    Πρωταρχικός στόχος είναι η διερεύνηση της δυνατότητας ταχείας παραγωγής πολυπαθογονο-ειδικών Τ-λεμφοκυττάρων από τον δότη με πενταπλή ειδικότητα έναντι παθογόνων και της ασφάλειας χορήγησής τους ως θεραπεία σε μεταμοσχευμένους ασθενείς με ενεργείς ιικές και μυκητιακές λοιμώξεις. Ως δεύτερος πρωτεύων στόχος ορίζεται η αξιολόγηση της επίδρασης των χορηγούμενων penta-STs στο φορτίο των παθογόνων, στην αποκατάσταση της αντι-ιικής και αντι-μυκητιακής ανοσίας και στην κλινική απόκριση.
    E.2.2Secondary objectives of the trial
    there are no secondary objectives
    Δεν εφαρμόζεται
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    N/A
    N/A
    E.3Principal inclusion criteria
    1)Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.

    2)Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF (see 2.2.1 definitions).

    3)Karnofsky/Lansky score of ≥ 50.

    4)ANC > 500/μl.

    5)Bilirubin ≤ 2x*, AST < 3x*, Serum creatinine ≤ 2x*, Hemoglobin > 8.0 g/dl.

    6)Pulse oximetry of > 90% on room air.

    7)Available pentavalent-specific T cells.

    8)Negative pregnancy test (if female of childbearing potential)

    9)Patient capable of providing informed consent.
    1)Υποβολή σε μυελοαφανιστική ή μη-μυελοαφανιστική αλλογενή μεταμόσχευση αιμοποιητικών στελεχιαίων κυττάρων.

    2)Αναζωπύρωση/λοίμωξη -από οποιονδήποτε εκ των 5 παθογόνων : AdV, CMV, EBV, BKV και AF

    3)Σκορ Karnofsky/Lansky ≥ 50.

    4)ANC > 500/μl.

    5)Χολερυθρίνη ≤ 2x*, AST < 3x*, Κρεατινίνη ορού ≤ 2x*, Αιμοσφαιρίνη> 8.0 g/dl.

    6)Παλμική οξυμετρία > 90% σε αέρα δωματίου.

    7)Διαθέσιμα penta-STs πολλαπλής ειδικότητας.

    8)Αρνητικό τεστ εγκυμοσύνης για τις θήλεις ασθενείς με δυνατότητα τεκνοποίησης.

    9)Ασθενής ικανός να δώσει ενυπόγραφη συγκατάθεση.
    E.4Principal exclusion criteria
    1)Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.

    2)Steroids > 0.5 mg/kg/day prednisone.

    3)Received donor lymphocyte infusion in last 28 days.

    4)GVHD ≥ grade 2.

    5)Active and uncontrolled relapse of malignancy.

    6)Patients with other uncontrolled infections
    1)Λήψη ATG, ή Campath ή άλλου μονοκλωνικού αντίσώματος που καταστέλλει τα Τ-λεμφοκύτταρα, τις τελευταίες 28 ημέρες.

    2)Στεροειδή >0.5mg/kg πρεδνιζόνης ημερησίως.

    3)Λήψη λεμφοκυττάρων του δότη τις τελευταίες 28 ημέρες.

    4)GvHD ≥ βαθμού 2.

    5)Ενεργή και μη ελεγχόμενη υποτροπή της κακοήθους νόσου.

    6)Εμφάνιση άλλων μη ελεγχόμενων λοιμώξεων (κεφάλαιο 2.2.2).
    E.5 End points
    E.5.1Primary end point(s)
    The primary objectives, for this phase I/II study are:

    1) the determination of the safety of cell therapy with penta-STs. The primary endpoint will be the safety of cell therapy with penta-STs. will be assessed according to: i) acute GvHD grades III-IV within 6 weeks of the last dose of penta-STs, ii) grades ≥3 infusion-related adverse events iii) grades ≥3 non hematological, adverse events within 30 days of the last penta-ST dose, which are not due to the preexisting infection/co-morbidities or the original malignancy.

    2) The efficacy of penta-STs, which will be determined based on:
    • pathogen loads and clinical symptoms in patients.
    • reconstitution of antiviral and antifungal immunity
    • viral reactivations or recurrence of AF infection post penta-STs infusion.
    Οι πρωταρχικοί στόχοι της παρούσης, φάσης I/ΙΙ μελέτης είναι :

    1) η διερεύνηση της ασφάλειας της κυτταρικής θεραπείας με penta-STs.
    2) Η αποτελεσματικότητα των penta-STs, η οποία θα εκτιμηθεί με βάση :
    • το φορτίο παθογόνων και την κλινική εικόνα των ασθενών
    • την αποκατάσταση της αντιικής και αντιμυκητιακής ανοσίας
    • τις ιικές αναζωπυρώσεις
    προϋπάρχουσες λοιμώξεις ή συννοσηρότητες ή στην αρχική κακοήθεια.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1)Safety will be assessed according to: i) acute GvHD grades III-IV within 6 weeks of the last dose of penta-STs, ii) grades ≥3 infusion-related adverse events iii) grades ≥3 non hematological, adverse events within 30 days of the last penta-ST dose, which are not due to the preexisting infection/co-morbidities or the original malignancy.

    2)Patients will be followed for acute toxicity for 30 days, acute and chronic GVHD for 6 weeks and 6 months respectively, anti-viral and antifungal responses for 6 months following the final VSTs infusion.
    1)1) η ασφάλεια και θα εκτιμηθεί βάσει: i) της εμφάνισης ή προόδου οξείας GvHD βαθμού III-IV εντός 6 εβδομάδων μετά την τελευταία χορήγηση penta-STs, ii) της εμφάνισης επιπλοκών σχετιζόμενων με την έγχυση, βαθμού ≥3 και iii) της εμφάνισης μη αιματολογικών παρενεργειών βαθμού ≥3 , μέχρι 30 ημέρες από την τελευταία χορήγηση penta-STs, οι οποίες δεν οφείλονται σε
    προϋπάρχουσες λοιμώξεις ή συννοσηρότητες ή στην αρχική κακοήθεια.

    2)Οι ασθενείς θα ελέγχονται για εμφάνιση οξείας τοξικότητας 30 ημέρες, οξείας και χρόνιας GvHD για 6 εβδομάδες και 6 μήνες αντίστοιχα και για την αντι-ιική και αντι-μυκητιακή απόκριση 6 μήνες
    E.5.2Secondary end point(s)
    Ν/Α
    Ν/Α
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ν/Α
    Ν/Α
    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.6.13.1Other scope of the trial description
    Ν/Α
    Ν/Α
    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
    First Administration of T cells in AdV, CMV, EBV, BKV and Aspergillus fumigatus infections
    Χoρήγηση Τ-λεμφοκυττάρων για πρώτη φορά στα πλαίσια λοίμωξεων από AdV, CMV, EBV, BKV και Aspergillus
    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 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 No
    E.8.1.7.1Other trial design description
    Ν/Α
    Ν/Α
    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.8.2.3.1Comparator description
    Ν/Α
    Ν/Α
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    LVLS
    Τελευταία Επίσκεψη Τελευταίου Ασθενούς
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    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: 10
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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.3.3.6.1Details of subjects incapable of giving consent
    N/A
    N/A
    F.3.3.7Others No
    F.3.3.7.1Details of other specific vulnerable populations
    N/A
    N/A
    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)
    As described in protocol and according to everything required for the care of transplanted patients
    Όπως αναφέρεται στο πρωτόκολλο και σύμφωνα με ότι απαιτείται για την μεταμοσχευματική περίθαλψη των συμμετεχόντων.
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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