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    Summary
    EudraCT Number:2021-003445-37
    Sponsor's Protocol Code Number:ELPIDA-ALLOCART-01
    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 number2021-003445-37
    A.3Full title of the trial
    A Phase 2 Study of the Efficacy and Safety of a Dose of Donor-Derived CD19-targeted CAR T cells for children and young adults (up to 39 years old) with recurrent or persistent CD19 (+) Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
    Κλινική Μελέτη φάσης 2 για την αποτελεσματικότητα και την ασφάλεια χορήγησης αλλογενών Τ λεμφοκυττάρων με χιμαιρικό υποδοχέα αντι-CD19 (CAR-T) σε ασθενείς με υποτροπιάζουσα ή ανθεκτική CD19+ Οξεία Λεμφοβλαστική Λευχαιμία μετά από αλλογενή μεταμόσχευση αρχέγονων αιμοποιητικών κυττάρων
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of the Efficacy and Safety of a Dose of Donor-Derived CD19-targeted CAR T cells
    Κλινική Μελέτη φάσης 2 για την αποτελεσματικότητα και την ασφάλεια χορήγησης αλλογενών Τ λεμφοκυττάρων με χιμαιρικό υποδοχέα αντι-CD19 (CAR-T)
    A.4.1Sponsor's protocol code numberELPIDA-ALLOCART-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 SponsorAghia Sophia Children’s Hospital
    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 supportAghia Sophia Children’s Hospital
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAghia Sophia Children’s Hospital
    B.5.2Functional name of contact pointEvgenios Goussetis
    B.5.3 Address:
    B.5.3.1Street AddressLevadias 8
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code11527
    B.5.3.4CountryGreece
    B.5.6E-mailevgoussetis@gmail.com
    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 nameDDCAR-CD19 T-cells
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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
    Relapsed b Acute Lymphoblastic Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation
    Υποτροπιάζουσα β- Οξεία Λεμφοβλαστική Λευχαιμία μετά από αλλογενή μεταμόσχευση αρχέγονων αιμοποιητικών κυττάρων
    E.1.1.1Medical condition in easily understood language
    Relapsed Acute Leukemia
    Υποτροπιάζουσα Οξεία Λευχαιμία
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10063620
    E.1.2Term Acute lymphocytic leukaemia recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of the infusion of DDCAR-CD19 cells
    To evaluate the incidence of aGVHD and cGVHD.
    To determine both quantitatively and qualitatively the generation of CAR-T cells using the CliniMACS Prodigy device.
    Η αξιολόγηση της αποτελεσματικότητας και της ασφάλειας της ενδοφλέβιας χορήγησης των DDCAR-CD19 Τ λεμφοκυττάρων.
    Η εκτίμηση της επίπτωσης οξείας ή χρόνια νόσου μοσχεύματος έναντι ξενιστή.
    Η ποσοτική και ποιοτική εκτίμηση της δημιουργίας CAR-T κυττάρων χρησιμοποιώντας τo CliniMACS Prodigy.
    E.2.2Secondary objectives of the trial
    To evaluate the duration of in vivo persistence of adoptively transferred DDCAR-CD19 cells.
    To evaluate B-cell aplasia.
    Η αξιολόγηση της διάρκειας της in vivo παραμονής (persistence) των DDCAR-CD19 Τ λεμφοκυττάρων με την χρήση κυτταρομετρίας ροής.
    Η αξιολόγηση της Β κυτταρικής απλασίας.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Individuals between 6 months and 39 years of age who have recurrent or persistent CD19 (+) acute leukemia after allogeneic HSCT or following autologous CAR-T cell therapy
    - ≥5 X 10-4 CD19+ blast cells in bone marrow as determined per flow cytometry, or isolated extramedullary relapse.
    - No evidence of ≥ grade II aGVHD or chronic GVHD while off of systemic immunosuppressive therapy for at least 4 weeks.
    - Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50
    - Availability of the initial stem cell donor.
    Άτομα ηλικίας μεταξύ 6 μηνών και 39 ετών με υποτροπιάζουσα ή ανθεκτική CD19+ οξεία λευχαιμία >12 εβδομάδες μετά από αλλογενή μεταμόσχευση ή μετά από θεραπεία με αυτόλογα CAR-T κύτταρα.
    >5% διήθηση μυελού από CD19+ βλαστικά κύτταρα διαγνωσμένη μετά από κυτταρομετρία ροής, ή μεμονωμένη εξωμυελική υποτροπή.
    Μη επιλέξιμοι ασθενείς για θεραπεία με αυτόλογα CAR-T κύτταρα.
    Σε περίπτωση προηγηθείσας χορήγησης λεμφοκύτταρων δότη, η τελευταία δόση αυτών θα πρέπει να απέχει τουλάχιστον 28 ημέρες από την λευκαφαίρεση για την παραγωγή των αντι-CD19 CAR-T κυττάρων.
    Να μην υπάρχει νόσος μοσχεύματος έναντι ξενιστή ή να υπάρχει ένδειξη ελάχιστης οξείας ή χρόνιας νόσου μοσχεύματος έναντι ξενιστή μετά την διακοπή της ανοσοκατασταλτικής αγωγής για τουλάχιστον 4 εβδομάδες.
    Κατάσταση ικανότητας Lansky (ηλικία<16 έτη κατά την υπογραφή ενημερωμένης συγκατάθεσης) ή Karnofsky (ηλικία>16 έτη κατά την υπογραφή ενημερωμένης συγκατάθεσης) >50.
    Διαθεσιμότητα του αρχικού δότη στελεχιαίων αιμοποιητικών κυττάρων.
    E.4Principal exclusion criteria
    Active severe infection
    Active aGVHD Grade ≥II
    <30% expression of CD19 on the leukemic population
    Presence of a CD19-negative leukemic subclone
    Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids
    Eligible for therapy with recipient-derived CAR-T cells
    Ενεργός σοβαρή λοίμωξη.
    Ενεργή νόσος μοσχεύματος έναντι ξενιστή > στάδιο ΙΙ.
    <30% έκφραση του CD19 στον λευχαιμικό πληθυσμό.
    Ύπαρξη CD19 αρνητικού λευχαιμικού κλώνου.
    Μέτρια/σοβαρή χρόνια νόσος μοσχεύματος έναντι ξενιστή (ΝΙΗ κριτήρια ) που απαιτεί την χορήγηση συστηματικά κορτικοστεροϊδών.
    Επιλέξιμοι ασθενείς για θεραπεία με αυτόλογα CAR-T κύτταρα.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion.
    DDCART-CD19 product purity and Transduction Efficiency
    Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion
    Αριθμός ασθενών σε πλήρη ύφεση της νόσου στις 30 ημέρες μετά την έγχυση των DDCART-CD19 λεμφοκυττάρων.
    Αριθμός και καθαρότητα των εγχυμένων DDCART-CD19 κυττάρων και αποδοτικότητα της διαμόλυνσης με το SIN Λεντιιό.
    Αριθμός ασθενών σε πλήρη ύφεση στους 6, 12, και 24 μήνες μετά την έγχυση των DDCART-CD19 λεμφοκυττάρων.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 6, 12, and 24 months
    1, 6, 12, και 24 μήνες
    E.5.2Secondary end point(s)
    Duration of DDCART cell detection in patients’ blood
    Duration of B-cell aplasia
    Correlation of DDCART cell and B-cells detection with disease relapse
    Διάρκεια ανίχνευσης των DDCART-CD19 κυττάρων στο αίμα του ασθενούς
    Διάρκεια της απλασίας των Β-λεμφοκυττάρων
    Συσχέτιση της διάρκειας ανίχνευσης των DDCART-CD19 κυττάρων και της απλασίας των Β-λεμφοκυττάρων με την πιθανότητα υποτροπής της νόσου
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 12, 18 and 24 months
    3, 6, 12, 18 και 24 μήνες
    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 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) No
    E.7.1.1First administration to humans No
    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 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 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 concerned3
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number of subjects for this age range: 4
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    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: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children under 10 years old
    παιδιά κάτω των 10 ετών
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children under 10 years old
    παιδιά κάτω των 10 ετών
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    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 Decision2021-09-30
    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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