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    Summary
    EudraCT Number:2018-003574-28
    Sponsor's Protocol Code Number:THYTECH1-2018-005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-003574-28
    A.3Full title of the trial
    Phase I / II clinical trial, randomized, exploratory and prospective to evaluate the safety and efficacy of the transfusion of autologous TREG cells obtained from thymic tissue in the prevention of rejection in heart transplanted children
    Ensayo clínico fase I/II aleatorizado, exploratorio y prospectivo para evaluar la seguridad y eficacia de la transfusión de células TREG autólogas obtenidas de tejido tímico en la prevención del rechazo en niños trasplantados de corazón
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I / II clinical trial, randomized, exploratory and prospective to evaluate the safety and efficacy of the transfusion of autologous TREG cells obtained from thymic tissue in the prevention of rejection in heart transplanted children
    Ensayo clínico fase I/II aleatorizado, exploratorio y prospectivo para evaluar la seguridad y eficacia de la transfusión de células TREG autólogas obtenidas de tejido tímico en la prevención del rechazo en niños trasplantados de corazón
    A.4.1Sponsor's protocol code numberTHYTECH1-2018-005
    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 SponsorRafael Correa Rocha
    B.1.3.4CountrySpain
    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 supportRafael Correa Rocha
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRafael Correa Rocha
    B.5.2Functional name of contact pointRafael Correa Rocha
    B.5.3 Address:
    B.5.3.1Street AddressCalle del Dr. Esquerdo, 46
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.6E-mailrafael.correa@iisgm.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 nameCélulas linfocíticas Treg, diferenciadas, autólogas, de tejido tímico, expandidas y estimuladas con
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNthyTreg
    D.3.9.3Other descriptive nameAUTOLOGOUS T-LYMPHOCYTES
    D.3.9.4EV Substance CodeSUB96123
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10000000 to 20000000
    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
    To evaluate the efficacy in the prevention of the rejection of the transfusion of autologous thyTreg cells in children transplanted from the heart
    Evaluar la eficacia en la prevención del rechazo de la transfusión de células thyTreg autólogas en niños trasplantados de corazón.
    E.1.1.1Medical condition in easily understood language
    To evaluate the efficacy in the prevention of the rejection of the transfusion of autologous thyTreg cells in children transplanted from the heart
    Evaluar la eficacia en la prevención del rechazo de la transfusión de células thyTreg autólogas en niños trasplantados de corazón.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 main objective is to evaluate the feasibility, safety and efficacy of the infusion of autologous thyTreg cells in the prevention of acute rejection in children transplanted from the heart.
    El objetivo principal consiste en evaluar la factibilidad, seguridad y eficacia de la infusión de células thyTreg autólogas en la prevención del rechazo agudo en niños trasplantados de corazón.
    E.2.2Secondary objectives of the trial
    To evaluate the recovery of the population of circulating Treg and its phenotype throughout the follow-up, the immunological state of the patient, and the reduction of the immunological markers associated with rejection.
     Determine the incidence of episodes of acute rejection in the 2 years following transplantation and determine the efficacy of treatment in the prevention of these episodes.
     Assess the tolerability of the product under investigation
    Evaluar la recuperación de la población de Treg circulantes y su fenotipo a lo largo del seguimiento, el estado inmunológico del paciente, y la reducción de los marcadores inmunológicos asociados a rechazo.
     Determinar la incidencia de episodios de rechazo agudo en los 2 años siguientes al trasplante y determinar la eficacia del tratamiento en la prevención de estos episodios.
     Valorar la tolerabilidad del producto en investigación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patient under two years of age, who meets all the requirements necessary to undergo a heart transplant.
    2) Patients without contraindication to immunosuppressive drugs.
    3) Parents and / or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document.
    1) Paciente menor de dos años de edad, que cumpla todos los requisitos necesarios para ser sometido a un trasplante de corazón.
    2) Pacientes sin contraindicación a los fármacos inmunosupresores.
    3) Los padres y/o tutores deben estar dispuestos y ser capaces de comprender el propósito y los riesgos del estudio y deben firmar el documento de consentimiento informado.
    E.4Principal exclusion criteria
    1) Patients with DiGeorge Syndrome, since their thymic function is affected.
    2) HIV positive serology.
    3) Active infection by EBV
    4) Patients hyperimmunized with cytotoxic anti-HLA antibodies
    5) Patients with a history of prior malignancy
    6) Patients who have participated in other intervention studies in the last month.
    7) Patients who have received induction therapy with Basiliximab or Thymoglobulin.
    8) Patients who have been previously transplanted.
    9) Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
    1) Pacientes con Síndrome de DiGeorge, ya que su función tímica está afectada.
    2) Serología HIV positiva.
    3) Infección activa por EBV
    4) Pacientes hiperinmunizados con anticuerpos citotóxicos anti-HLA
    5) Pacientes con historia de malignidad previa
    6) Pacientes que hayan participado en otros estudios de intervención en el último mes.
    7) Pacientes que hayan recibido terapia de inducción con Basiliximab o Timoglobulina.
    8) Pacientes que hayan sido trasplantados previamente.
    9) Pacientes que hayan sido diagnosticados de enfermedad autoinmune grave (celiaquía, hipotiroidismo autoinmune, diabetes autoinmune)
    E.5 End points
    E.5.1Primary end point(s)
    Repopulation of Treg cells in the patient, determined as the increase of their blood values ​​and the recovery of the ratio Treg / T-effector cells with respect to the values ​​prior to transplantation
    Repoblación de células Treg en el paciente, determinado como el aumento de sus valores en sangre y la recuperación del ratio células Treg/T-efectoras con respecto a los valores previos al trasplante
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    E.5.2Secondary end point(s)
    Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography and / or biopsy) that requires treatment in the 2 years post-transplant
     Restoration of immunological homeostasis in terms of values ​​of immune populations. The percentages and absolute values ​​of T, B, NK and Treg lymphoid populations and of monocytes, dendritic cells and granulocytes during the post-transplant follow-up period (+7, +14, +21, +30, +60, +90, +120, +150, +180, +270, +365, +545, +730 days)
     Survival of the patient
     Security (according to criteria NCI-CTCAE V4.03)
    Incidencia de episodios de rechazo miocárdico agudo (diagnosticado por ecocardiografía y/o biopsia) que precise tratamiento en los 2 años post-trasplante
     Restauración de la homeostasis inmunológica en términos de valores de poblaciones inmunes. Se analizarán los porcentajes y valores absolutos de poblaciones linfoides T, B, NK y Treg, y de monocitos, células dendríticas y granulocitos durante el periodo de seguimiento post-trasplante (+7, +14, +21, +30, +60, +90, +120, +150, +180, +270, +365, +545, +730 días)
     Superviviencia del paciente
     Seguridad (según los criterios NCI-CTCAE V4.03)
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The 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
    LVLS
    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 months
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 5
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    NIños
    F.3.3.7Others No
    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)
    N/A
    N/A
    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 Decision2019-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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