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    Summary
    EudraCT Number:2018-000911-25
    Sponsor's Protocol Code Number:BST-LT-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-09
    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 number2018-000911-25
    A.3Full title of the trial
    A prospective multicenter open, not controlled phase Ib-II clinical trial to assess the safety and immunologic efficacy of virus-specific T lymphocytes from the best donor in receptors of hematopoietic progenitor allogeneic transplant
    Ensayo clínico fase Ib-II, prospectivo, multicéntrico, abierto y no controlado para evaluar la seguridad y eficacia inmunológica de la infusión de linfocitos T específicos frente a virus a partir del mejor donante disponible en receptores de un trasplante alogénico de progenitores hematopoyéticos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the effect of virus-specific activated T lymphocytes from a donor in hematopoietic progenitor transplanted patients
    Ensayo clínico para evaluar los efectos de linfocitos T de donante activados contra un virus específico en pacientes receptores de un trasplante de progenitores hemaopoyéticos
    A.4.1Sponsor's protocol code numberBST-LT-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 SponsorBanc de Sang i Teixits
    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 supportBanc de Sang i Teixits
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportVHIO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBanc de Sang i Teixits
    B.5.2Functional name of contact pointResearch and Education
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Taulat 116
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08005
    B.5.3.4CountrySpain
    B.5.4Telephone number349355735006707
    B.5.6E-mailrucoll@bst.cat
    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 nameViroTCell
    D.3.2Product code ViroTCell
    D.3.4Pharmaceutical form Suspension for injection
    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 INNNot available
    D.3.9.2Current sponsor codeViroTCell
    D.3.9.3Other descriptive namevirus-specific activated human T-Lympocytes
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 50000
    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
    CMV viral infection in an immunocompromised host
    Infección vírica por CMV en un huésped inmunodeprimido
    E.1.1.1Medical condition in easily understood language
    viral infection in a patient with low defenses
    Infección vírica en paciente con pocas defensas
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021819
    E.1.2Term Infection in marrow transplant recipients
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the safety of ViroTCell administration to the recipient in the post-transplant period
    1.Evaluar la seguridad de la administración de ViroTCell tras ser transfundidos al receptor en el periodo postrasplante.
    E.2.2Secondary objectives of the trial
    1-Efficacy of the ViroTCell infusion for the treatment of infection assessed by Viral Load (PCR) and Clinical assessment
    2-Immune reconstitution ability aginst virus
    3-Persistence studies of virus-specific T cells using chimerism techniques
    4-Time elapsed until a donor is identified
    1-Eficacia de la infusión de ViroTCell para el tratamiento de la infección mediante Carga viral por PCR y Evaluación clínica
    2-Capacidad para inducir reconstitución inmune frente al virus
    3-Estudios de persistencia de las células T específicas mediante técnicas de quimerismo
    4-Tiempo transcurrido en identificar al donante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure
    2. Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases
    a) Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment
    b) Patient with CMV reactivation and no organic disease, resistant or intolerant to 2 previous antiviral treatment lines (ganciclovir/valganciclovir and foscarnet) or not candidate to be treated due to not acceptable expected toxicity (severe renal insufficiency, neutropenia or severe thrombopenia)
    It is agreed that the patient is affected with a resistant CMV infection if the CMV copies doesn’t decrease in > 1 log in total blood or otherwise the absolute number of copies > 1x10E4/mL in total blood after 2 weeks of antiviral treatment.
    c) Patients with reactivation of recurrent CMV despite correct anti-CMV treatment.
    It will be considered a recurrent CMV infection if the patient has> 2 reactivations in a period <6 months despite having received correct anti-CMV treatment
    d) Documented genetic mutations associated with ganciclovir or foscarnet resistance
    3. ≥ 1 year of age
    4. Estimated life expectancy > 30 days
    5. Signature of the informed consent form
    1. Receptor de un trasplante alogénico de progenitores hematopoyéticos (independientemente del donante, de la fuente de progenitores, del tipo de acondicionamiento y de la enfermedad de base) que se encuentre más allá del día +30 del procedimiento.
    2. Paciente con infección post-trasplante por CMV refractaria o resistente a tratamiento farmacológico óptimo. Específicamente el paciente deberá incluirse en alguno de los siguientes supuestos:
    a) Paciente con enfermedad orgánica por CMV (demostración histológica) resistente a primera línea de tratamiento antiviral.
    b) Paciente con reactivación de CMV sin enfermedad orgánica, resistente o intolerante a 2 líneas de tratamiento antiviral previas (ganciclovir/valganciclovir y foscarnet) o que no sea candidato a recibirlas por toxicidades esperables inaceptables (insuficiencia renal severa, neutropenia o trombopenia severas).
    Se considerará que el paciente sufre una infección por CMV resistente si no presenta disminución de las copias de CMV de > 1 log en sangre total o bien un número absoluto de copias > 1x10E4/mL en sangre total tras 2 semanas de tratamiento antiviral.
    c) Pacientes con reactivación de CMV recidivante a pesar de tratamiento correcto anti-CMV.
    Se considerará infección por CMV recidivante si el paciente presenta >2 reactivaciones en un periodo < 6 meses a pesar de haber recibido tratamiento correcto anti-CMV.
    d) Documentación de una o más mutaciones genéticas asociadas a resistencia a ganciclovir o foscarnet.
    3. Edad ≥ 1 año.
    4. Esperanza de vida estimada > 30 días
    5. Firma del consentimiento informado
    E.4Principal exclusion criteria
    1.Acute GVHD ≥ grade II or chronic ≥ moderate
    2.Corticosteroid ≥ 0.5mg/kg regardless the indication
    3.Disease relapse at the time of infection or at any time after the Allogeneic transplant.
    4.Severe renal disease (creatinine > 3gr/dL)
    5.Severe hepatic disease (bilirrubine >3mg/dL or AST >500 U/L) except if it is secondary to the viral infection.
    6.Having received a donor lymphocytes infusion or any cell therapy product within 60 days prior to inclusion in the study (with the exception of transfusions), or having it planned within the next 60 days.
    7.Alteration of the general condition, infection or clinical or hemodynamic instability that, in the opinion of the researcher, does not recommend the use of T cells
    8.Known hypersensitivity to murine proteins or iron dextran.
    9.Positive serology to HIV, HBV (HBsAg, HBcAc), HCV and/or syphilis
    10.Pregnant, lactating or women without adequate contraception (*)
    11.Participation in a clinical trial with investigational medicinal products the last 30 days
    (*) The effective contraceptive methods contemplated in the protocol are the hormonal ones, intrauterine device (IUD), barrier methods, voluntary sterilization or females with menopause > 1 year of duration.
    The criteria should be reviewed once the donor has been selected and before proceeding to the donor's lymphoapheresis to confirm that the patient is still a candidate for treatment.
    1.Enfermedad de injerto contra el huésped aguda ≥ grado II o crónica ≥ moderada
    2.Corticoides ≥ 0.5mg/kg para cualquier indicación
    3.Recaída de la enfermedad de base en el momento de la infección o en cualquier momento después del trasplante alogénico.
    4.Enfermedad renal severa (creatinina > 3gr/dL)
    5.Enfermedad hepática severa (bilirrubina >3mg/dL o AST >500 U/L) a no ser que se considere que la alteración es secundaria a la infección viral.
    6.Haber recibido infusión de linfocitos del donante o cualquier producto de terapia celular en los 60 días previos a la inclusión en el estudio (a excepción de transfusiones), o tener prevista su infusión en los siguientes 60 días.
    7.Alteración del estado general, infección o situación de inestabilidad clínica o hemodinámica que a criterio del investigador desaconsejen el uso de células T.
    8.Hipersensibilidad conocida a proteínas murinas o hierro dextrano.
    9.Serología positiva para HIV, VHB (HBsAg, HBcAc), VHC y/o lúes
    10.Mujeres embarazadas, lactantes o con capacidad de procrear sin un método anticonceptivo adecuado (*).
    11.Participación en un estudio con medicamentos en investigación en los últimos 30 días.
    (*) Los métodos anticonceptivos eficaces que se contemplaran en el protocolo son los hormonales, el dispositivo intrauterino (DIU), los métodos de barrera, la esterilización voluntaria o que la paciente tenga la menopausia de >1año de duración.
    Los criterios deberán revisarse una vez seleccionado el donante y antes de proceder a la linfoaféresis del donante para confirmar que el paciente continúa siendo candidato al tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    -Safety assessment through physical examination, vital signs, laboratory data and adverse events. The development of acute GVHD will be measured by the Seattle modified criteria
    -Evaluación de la seguridad mediante exploración física, constantes vitales, datos de laboratorio y acontecimientos adversos. El desarrollo de EICH aguda se medirá mediante los criterios modificados de Seattle.
    E.5.1.1Timepoint(s) of evaluation of this end point
    +7, +14, +21, +28, +45, +60 days
    +7, +14, +21, +28, +45, +60 días
    E.5.2Secondary end point(s)
    -PCR quantitative viral load for CMV at +7, +14, +21, +28, +45, +60 days
    -Immune reconstitution against CMV using Elispot at +7, +14, +28, +60 days
    -Immune reconstitution against CMV by flow cytometry at +7, +14, +28, +60 days
    -T-cell persistence by chimerism: detection of donor cellularity (administered product) in the receptor serum at +14 y +28 days
    -Time elapsed in identifying the donor. The type of donor available at the time of patient’s inclusion, the type of donor finally selected and the time elapsed from the inclusion of the patient to the date of selection of the donor (date of the stimulation test of the selected donor).
    -Carga viral por PCR cuantitativa para CMV a los +7, +14, +21, +28, +45, +60 d
    -Reconstitución inmune frente a virus CMV por Elispot a los +7, +14, +28, +60 d
    -Reconstitución inmune frente a virus CMV por citometría de flujo a los +7, +14, +28, +60 d
    -Persistencia de células T mediante quimerismo: presencia o ausencia de celularidad del donante (producto infundido) en suero del receptor a los +14 y +28d
    -Tiempo transcurrido en identificar al donante. Se evaluará el tipo de donante disponible a la inclusión del paciente, el tipo de donante finalmente seleccionado y el tiempo transcurrido desde la inclusión del paciente a la fecha de selección del donante (fecha del test de estimulación del donante seleccionado).
    E.5.2.1Timepoint(s) of evaluation of this end point
    +7, +14, +21, +28, +45, +60 days
    +7, +14, +21, +28, +45, +60 días
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety study
    Estudio de seguridad
    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 concerned7
    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
    Last patient last visit
    Última visita del 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 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: 9
    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: 4
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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
    Pediatric population
    Población pediátrica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    Patients will follow periodic Medical visits based on their pathology. Patients with adverse events will be followed until resolution or stabilization, regardless whether they have finished the trial.
    Los pacientes seguiran controles médicos periódicos en base a su patologia. Los pacientes que hayan presentado acontecimientos adversos se seguiran hasta su resolución o estabilización independientemente de si han finalizado
    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 Decision2019-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
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