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    Summary
    EudraCT Number:2015-003362-84
    Sponsor's Protocol Code Number:FSJD-DIPG-DC
    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:2016-01-13
    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 number2015-003362-84
    A.3Full title of the trial
    Phase Ib clinical trial on the safety of immunotherapy with autologous dendritic cells primed with lysate allogeneic tumor lines in patients with diffuse intrinsic pontine glioma ( DIPG )
    Ensayo clínico fase Ib sobre la seguridad de la Inmunoterapia con células dendríticas autólogas pulsadas con lisado de líneas tumorales alogénicas en pacientes con glioma intrínseco difuso de tronco (DIPG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety study of DIPG treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines
    Estudio de seguridad del tratamiento de DIPG con células dendríticas autólogas cargadas con lisado tumoral alogénico
    A.4.1Sponsor's protocol code numberFSJD-DIPG-DC
    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 SponsorFundació Sant Joan de Déu
    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 supportFundacio Sant Joan de Déu
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Unit Hospital Clínic Barcelona
    B.5.2Functional name of contact pointCTU CLINIC
    B.5.3 Address:
    B.5.3.1Street AddressMallorca 183
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322754003343
    B.5.5Fax number0034932279877
    B.5.6E-mailsvarea@clinic.ub.es
    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 nameCél. dendríticas dif. adultas autólogas de sangre perif. expand. cargadas con lisado de lín. tumoral
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCélulas dendríticas diferenciadas adultas autólogas de sangre periférica expandidas cargadas con lisado de líneas tumoral
    D.3.9.3Other descriptive nameAutologous peripheral blood differenciated adult dendritic cells expanded loaded with tumor cell lysate
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 tumorales de glioma adultas alogénicas de líneas celulares de DIPG lisadas e irradiadas
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCélulas tumorales de glioma adultas alogénicas de líneas celulares de glioma intrínseco difuso de tronco lisadas e irradiadas
    D.3.9.3Other descriptive nameAlogenic glioma adult tumor cells of irradiated lysed cell lines of diffuse intrinsic pontine glioma
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    Diffuse intrinsic pontine glioma (DIPG)
    Glioma intrínseco difuso de tronco (DIPG)
    E.1.1.1Medical condition in easily understood language
    Diffuse intrinsic pontine glioma (DIPG)
    Glioma intrínseco difuso de tronco (DIPG)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10006143
    E.1.2Term Brain stem glioma
    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 assess the safety of a first in human administration of DCs vaccination pulsed with tumor lysate from a pool of eight K27M positive DIPG cell lines
    Evaluar la seguridad de una primera administración en humanos de la vacunación con CDs pulsadas con lisados procedentes de un pool de 8 líneas celulares de tumores DIPG K27M positivos en una cohorte de pacientes con DIPG
    E.2.2Secondary objectives of the trial
    Evaluate the nonspecific immune response generated in peripheral blood and CSF by proposed treatment
    Evaluate the specific antitumor immunity response generated in peripheral blood and CSF
    Assess overall survival and progression free survival
    Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF
    Quality of life evaluation
    Evaluar la respuesta inmunogénica inespecífica generada en sangre periférica y LCR
    Evaluar la respuesta inmunogénica antitumoral generada en sangre periférica y LCR
    Estudiar la supervivencia global y el periodo libre de progresión
    Relacionar los cambios neuroradiológicos con la evolución clínica y la respuesta inmunológica generada en sangre periférica y LCR.
    Calidad de vida se valorará mediante la evaluación prospectiva del performance de cada paciente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Newly diagnosed DIPG
    Patients without progressive disease
    Aged between 3 and 18 yo
    Lansky scale >50 (Karnosfsky for patients aged more than 16 yr)
    Life expectancy > 8 weeks
    Preserved bone marrow function
    Normal hepatic and renal function
    Pacientes con el diagnóstico reciente de DIPG
    Pacientes que hayan completado radioterapia focal en los 100 días previos a la inclusión
    Edad esté comprendida entre los 3 y 18 años de edad
    Escala funcional de Lansky> 50 ( Karnofsky> 50 para los mayores de 16 años)
    Expectativa de vida mayor a 8 semanas
    Función medular conservada
    No haber recibido tratamiento farmacológico antitumoral en el último mes
    E.4Principal exclusion criteria
    Impossibility to perform aphaeresis
    Patient part of other experimental study within the last 3 months
    Patient under antitumor treatment in the last 4 weeks
    Co-morbidity that does not allow the study treatment
    Patients requiring > 2mg/day of dexametasone treatment
    Corticoid-dependent patients
    Patients under uncontrolled infection
    Positive serologies of HIV, HCV or HBV
    Imposibilidad de realizar aféresis
    Participación en otro estudio experimental en los últimos tres meses
    Paciente que ha recibido tratamiento antitumoral las últimas 4 semanas
    Comorbilidad que impida tolerar el tratamiento en estudio
    pacientes que requieren >2mg/día de dexametasona
    pacientes corticoide-dependientes
    Pacientes con enfermedad diseminada
    Paciente con alguna infección incontrolada
    Serologías positivas de VIH, VHC o VHB
    E.5 End points
    E.5.1Primary end point(s)
    Number of serious adverse events per patient (after treatment administration)
    Número de acontecimientos adversos graves (AAG) por paciente tras la primera administración del tratamiento en estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    E.5.2Secondary end point(s)
    Overall survival
    Progression free survival
    Time to first SAE (after treatment)
    Immunologic parameters
    Changes in radiological images
    Relationship between immunological response and clinical response
    Relationship between histological, and molecular characterization, and clinical and cellular response generated by vaccination
    Safety parameters evaluation
    Performance
    Tiempo de supervivencia global
    Tiempo libre de progresión
    Tiempo hasta primer AAG (tras la administración del tratamiento en estudio)
    Evaluación de parámetros inmunológicos
    Evaluación de cambios radiológicos
    Relación de la presencia de respuesta inmunológica con evolución clínica.
    Relación entre la caracterización histológica y molecular, la respuesta clínica y la respuesta celular
    Evaluación de parámetros de seguridad
    Evaluación del performance
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    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 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) 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 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 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 Yes
    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
    última visita de último paciente
    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
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    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) 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 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.3.3.7Others 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)
    same treatment through compasionate use
    recibir misma pauta en estudio a través del uso compasivo
    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 Decision2016-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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