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    Summary
    EudraCT Number:2017-001965-26
    Sponsor's Protocol Code Number:AUTO4-TL1
    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:2019-12-02
    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 number2017-001965-26
    A.3Full title of the trial
    A SINGLE ARM, OPEN-LABEL, MULTI-CENTRE, PHASE I/II STUDY EVALUATING THE SAFETY AND CLINICAL ACTIVITY OF AUTO4, A CAR T CELL TREATMENT TARGETING TRBC1, IN PATIENTS WITH RELAPSED OR REFRACTORY TRBC1 POSITIVE SELECTED T CELL NON-HODGKIN LYMPHOMA
    ESTUDIO DE FASE I/II, MULTICÉNTRICO, ABIERTO Y DE UN SOLO GRUPO PARA EVALUAR LA SEGURIDAD Y LA ACTIVIDAD CLÍNICA DE AUTO4, UN
    TRATAMIENTO DE LINFOCITOS T-CAR DIRIGIDO A TRBC1, EN PACIENTES CON LINFOMA NO HODGKIN DE LINFOCITOS T SELECCIONADO TRBC1
    POSITIVO RECIDIVANTE O REFRACTARIO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II study evaluating AUTO4 (an experimental drug derived from the patient's own blood) in patients with T Cell Lymphoma (a type of blood cancer)
    Estudio de fase I/II para evaluar AUTO4 (un medicamento experimental derivado de la sangre del propio paciente) en pacientes con linfoma de linfocitos T (un tipo de cáncer de la sangre
    A.4.1Sponsor's protocol code numberAUTO4-TL1
    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 SponsorAutolus Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAutolus Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAutolus Ltd
    B.5.2Functional name of contact pointClinical Project manager
    B.5.3 Address:
    B.5.3.1Street AddressForest House, 58 Wood Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 7RZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402038296230
    B.5.6E-mailclinicaltrials@autolus.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 nameAUTO4
    D.3.2Product code AUTO4
    D.3.4Pharmaceutical form Dispersion for infusion
    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 INNn/a
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAUTO4
    D.3.9.3Other descriptive nameAUTOLOGOUS T CELLS GENETICALLY MODIFIED WITH A RETROVIRAL VECTOR TO EXPRESS RQR8 AND ANTI-TRBC1-CHIMERIC ANTIGEN RECEPTOR
    D.3.9.4EV Substance CodeSUB187426
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 225
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 or refractory T cell Non-Hodgkin Lymphoma (T-NHL)
    LNH de linfocitos T seleccionado recidivante o refractario
    E.1.1.1Medical condition in easily understood language
    T cell Non-Hodgkin Lymphoma (T-NHL) is a type of blood cell cancer that develop from lymphocytes (a type of white blood cell).
    El linfoma no Hodgkin de linfocitos T (LNH-T) es un tipo de cáncer de la sangre que se desarrolla a partir de los linfocitos (un tipo de glóbulo blanco).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025321
    E.1.2Term Lymphomas non-Hodgkin's T-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I:
    To assess the safety and tolerability of AUTO4 administration.
    To identify the recommended phase II dose (RP2D) and maximum tolerated dose (MTD), if an MTD exists.

    Phase II:
    To assess the safety and clinical activity of AUTO4 when administered at the RP2D
    Fase I:
    Evaluar la seguridad y la tolerabilidad de la administración de AUTO4.
    Identificar la dosis recomendada para la fase II (DRF2) y la dosis
    máxima tolerada (DMT), si hay una DMT, de AUTO4.
    Fase II:
    Evaluar la actividad clínica de AUTO4 cuando se administra a la DRF2.
    E.2.2Secondary objectives of the trial
    To assess the overall safety and tolerability of AUTO4.
    To evaluate the feasibility of generating the AUTO4.
    To evaluate the overall clinical efficacy of AUTO4.
    To determine the expansion and persistence of AUTO4 following infusion.
    Duration of TRBC1 positive T cell aplasia.
    Evaluar la seguridad y la tolerabilidad globales de AUTO4.
    Evaluar la factibilidad de generar AUTO4.
    Evaluar la eficacia clínica global de AUTO4.
    Determinar la expansión y la persistencia de AUTO4 después de la perfusión.
    Duración de la aplasia de los linfocitos T TRBC1 positivos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged ≥18 years.
    2. Willing and able to give written, informed consent to the study.
    3. Confirmed diagnosis of selected T-NHL including:
    a. Peripheral T cell lymphoma, not otherwise specified (NOS), or
    b. Angioimmunoblastic T cell lymphoma or
    c. Anaplastic large cell lymphoma.
    4. Confirmed TRBC1 positive tumour.
    5. Relapse or refractory disease and have had ≥1 prior lines of therapy.
    6. Positron emission tomography (PET)-positive measurable disease per Lugano classification.
    7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
    8. Adequate Bone Marrow Function without the requirement for ongoing blood products or and meets the following criteria:
    a. Absolute Neutrophil Count ≥1.0 x 10e9/L
    b. Absolute lymphocyte count ≥0.5 x 10e9/L (at entry and prior to leukapheresis)
    c. Haemaglobin ≥80g/L
    d. Platelets ≥75 x 10e9/L
    9. Adequate renal, hepatic, pulmonary, and cardiac function defined as:
    a. Creatinine clearance (as estimated by Cockcroft Gault) ≥60 cc/min.
    b. Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal ULN.
    c. Total bilirubin ≤25 µmol/L (1.5 mg/dL), except in subjects with Gilbert’s syndrome.
    d. Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA) cardiac scan, unless the
    institutional lower limit of normal is lower
    e. Baseline oxygen saturation >92% on room air and ≤Grade 1 dyspnoea
    10. For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to preconditioning and confirmed before receiving the first dose of study treatment.
    1. Hombres o mujeres de ≥18 años.
    2. Estar dispuesto a y poder otorgar el consentimiento informado por escrito para una prueba de detección de LNH de linfocitos T TRBC1 positivo y entrar en el estudio principal.
    3. Diagnóstico confirmado de LNH de linfocitos T seleccionado, incluidos:
    a. linfoma periférico de linfocitos T sin especificar, o
    b. linfoma angioinmunoblástico de linfocitos T, o
    c. linfoma anaplásico de células grandes.
    4. Tumor TRBC1 positivo confirmado.
    5. Enfermedad recidivante o refractaria y haber recibido ≥1 línea de terapia previa.
    6. Enfermedad medible positiva mediante tomografía por emisión de positrones (TEP) según la clasificación de Lugano.
    7. Estado funcional de 0 a 1 del Grupo Oncológico Cooperativo del Este (ECOG).
    8. Función medular adecuada sin requerir soporte continuo con hemoderivados y reúne los siguientes criterios:
    a. Recuento absoluto de neutrófilos ≥1,0 x 109/l.
    b. Recuento absoluto de linfocitos ≥0,5 x 109/l (en la inclusión y antes de la leucaféresis).
    c. Hemoglobina ≥80 g/l.
    d. Plaquetas ≥75 x 109/l.
    9. Funciones renal, hepática, pulmonar y cardiaca adecuadas, definidas como:
    a. Aclaramiento de la creatinina (estimado con la fórmula de Cockcroft Gault) ≥60 cc/min.
    b. Alanina aminotransferasa/aspartato aminotransferasa en suero ≤2,5 × el límite superior de la normalidad (LSN).
    c. Bilirrubina total ≤25 ╬╝mol/l (1,5 mg/dl), excepto en pacientes con síndrome de Gilbert.
    d. Fracción de eyección ventricular izquierda (FEVI) ≥50 % (mediante ecocardiograma [ECO] o ventriculografía nuclear [MUGA]), a menos que el límite inferior de la normalidad del centro sea más bajo.
    e. Saturación de oxígeno basal ≥92 % con aire ambiente y disnea de grado ≤1.
    10. En las mujeres en edad fértil (definidas como <2 años desde la última menstruación o no quirúrgicamente estériles) se debe documentar un resultado negativo en una prueba de embarazo en suero u orina en la selección y antes del preacondicionamiento, y se debe confirmar antes de recibir la primera dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    1. Patients with T cell leukaemia.
    2. Females who are pregnant or lactating.
    3. Prior treatment with investigational or approved gene therapy or genetically engineered cell therapy product or allogeneic stem cell transplant.
    4. Known history or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, paresis, aphasia, stroke within the prior 3 months, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS.
    5. Current or history of CNS involvement by malignancy.
    6. Clinically significant, uncontrolled heart disease (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick-sinus syndrome, or electrocardiographic evidence of acute ischaemia or Grade 3 conduction system abnormalities unless the patient has a pacemaker) or a recent (within 12 months) cardiac event.
    a. Uncontrolled cardiac arrhythmia (rate-controlled atrial fibrillation are not excluded).
    b. Evidence of pericardial effusion.
    7. Patients with evidence of uncontrolled hypertension or with a history of hypertension crisis or hypertensive encephalopathy.
    8. Patients with a recent history or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning.
    9. Patients with active gastrointestinal (GI) bleeding.
    10. Patients with any major surgical intervention in the last 3 months.
    11. Active infectious bacterial, viral disease or fungal disease (hepatitis B virus,hepatitis C virus, human immunodeficiency virus [HIV], human T cell lymphotropic virus [HTLV] or syphilis) requiring treatment.
    12. Active autoimmune disease requiring immunosuppression.
    13. History of other neoplasms unless disease free for at least 2 years (adequately treated carcinoma in situ, curatively treated non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).
    14. Prior treatment with programmed cell death protein 1 (PD1), programmed death-ligand 1 (PD-L1), or cytotoxic T lymphocyte-associated protein 4 (CTLA-4) targeted therapy, or tumour necrosis factor (TNF) receptor superfamily agonists including CD134 (OX40), CD27, CD137 (41BB), and
    CD357 (glucocorticoid-induced TNF receptor family-related protein) within 6 weeks prior to AUTO4 infusion.
    15. The following medications are excluded:
    a. Steroids: Therapeutic doses of corticosteroids within 72 hours of leukapheresis or pre-conditioning chemotherapy administration. However, physiological replacement, topical, and inhaled steroids are permitted.
    b. Cytotoxic chemotherapies within 2 weeks prior to leukapheresis or AUTO4 infusion.
    c. Antibody therapy use within 2 weeks prior to AUTO4 infusion, or five half-lives of the respective antibody, whichever is shorter.
    d. Live vaccine within 4 weeks prior to enrolment.
    16. Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
    17. Use of rituximab within the last 6 months prior to AUTO4 infusion.
    18. Patients, who in the opinion of the Investigator, may not be able to understand or comply with the safety monitoring requirements of the study.
    1. Pacientes con leucemia de linfocitos T.
    2. Mujeres embarazadas o en periodo de lactancia.
    3. Tratamiento previo con terapia génica en investigación o autorizada, o medicamentos de terapia celular elaborados por ingeniería genética, o trasplante alogénico de células progenitoras.
    4. Antecedentes conocidos o presencia de patología clínicamente relevante del sistema nervioso central (SNC) como epilepsia, paresia, afasia, ictus en los últimos 3 meses, lesión cerebral grave, demencia, enfermedad de Parkinson, enfermedad cerebelosa, síndrome cerebral orgánico, enfermedad mental sin controlar o psicosis. Pacientes con antecedentes conocidos o un diagnóstico previo de neuritis óptica u otra enfermedad inmunológica o inflamatoria que afecte al SNC.
    5. Pacientes con antecedentes o presencia de afectación del SNC por una neoplasia maligna.
    6. Enfermedad cardiaca no controlada y clínicamente significativa (insuficiencia cardiaca de clase III o IV de la Asociación Cardiaca de Nueva York, angina no controlada, arritmia ventricular grave no
    controlada, síndrome del seno enfermo o indicios electrocardiográficos de isquemia aguda o trastornos del sistema de conducción de grado 3, a menos que el paciente tenga un marcapasos) o un acontecimiento cardiaco reciente (en los últimos 12 meses).
    a. Arritmia cardiaca no controlada (no se excluye a los pacientes con fibrilación auricular con la frecuencia controlada).
    b. Indicios de derrame pericárdico.
    7. Pacientes con indicios de hipertensión no controlada o con antecedentes de crisis hipertensiva o encefalopatía hipertensiva.
    8. Pacientes con antecedentes (en los últimos 3 meses) o indicios de trombosis venosa profunda o embolia pulmonar que requieren
    anticoagulación terapéutica continua en el momento del preacondicionamiento.
    9. Pacientes con hemorragia gastrointestinal (GI) activa.
    10. Pacientes con cualquier intervención quirúrgica mayor en los últimos 3 meses.
    11. Enfermedad infecciosa bacteriana, viral o fúngica activa (virus de la hepatitis B, virus de la hepatitis C, virus de la inmunodeficiencia humana [VIH], virus linfotrópico humano de linfocitos T [VLHT] o sífilis) que requiere tratamiento.
    12.Enfermedad autoinmunitaria activa que requiere inmunosupresión.
    13. Antecedentes de otras neoplasias malignas salvo que el paciente lleve al menos 2 años sin enfermedad (se permiten el carcinoma in situ tratado adecuadamente, la neoplasia cutánea no melanoma tratado curativamente y el cáncer de mama o de próstata que recibe tratamiento hormonal).
    14. Tratamiento previo con proteína 1 de muerte celular programada (PD1), ligando 1 de muerte celular programada (PD-L1), o tratamiento citotóxico dirigido a la proteína 4 asociada a los linfocitos T, o agonistas de la superfamilia de receptores del factor de necrosis tumoral (TNF), incluidos CD134 (OX40), CD27, CD137 (41BB) y CD357 (proteína relacionada con la familia de receptores de TNF inducidos por glucocorticoides) en las 6 semanas anteriores a la perfusión de AUTO4.
    15. Se excluyen los medicamentos siguientes:
    a. Esteroides: dosis terapéuticas de corticoesteroides en las 72 horas anteriores a la leucaféresis o a la administración de la quimioterapia de preacondicionamiento. Sin embargo, se permiten los esteroides de reposición fisiológica, tópicos e inhalados.
    b. Quimioterapias citotóxicas en las 2 semanas anteriores a la leucaféresis o a la perfusión de AUTO4.
    c. Tratamiento con anticuerpos en las 2 semanas anteriores a la perfusión de AUTO4, o 5 semividas del anticuerpo respectivo, el periodo que sea más corto.
    d. Vacunas con virus vivos en las 4 semanas anteriores a la inclusión.
    16. Participantes en un estudio de investigación que reciben otro medicamento en investigación, o tratamiento biológico, de quimioterapia
    o de radiación de forma concurrente.
    17. Uso de rituximab (o biosimilar de rituximab) en los últimos 6 meses antes de la perfusión de AUTO4.
    18. Pacientes que, en opinión del investigador, podrían no entender o no cumplir los requisitos de supervisión de la seguridad del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of Grade 3 to 5 toxicity occurring within 60 days of AUTO4 infusion.
    Frequency of dose limiting toxicity (DLT) of AUTO4 within 28 days of AUTO4 infusion.
    Overall response (CR+PR) rate post AUTO4 infusion.
    Incidencia de toxicidad de grado 3 a 5 que se produce en los 60 días siguientes a la perfusión de AUTO4.
    Frecuencia de toxicidad limitante de la dosis (TLD) de AUTO4 en los 28 días siguientes a la perfusión de AUTO4.
    Criterio de valoración principal: Tasa de respuesta global (RC + RP) tras la perfusión de AUTO4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Safety endpoint evaluations will be conducted throughout the study
    - Grade 3-5 toxicity captured 60 days post dose
    - DLT Frequency within 28 days of AUTO4 infusion.
    - Overall response at 1, 3, 6, 9, 12, 15, 18 and 24 months post AUTO4 infusion.
    - Se realizarán evaluaciones de los criterios de valoración de seguridad durante todo el estudio.
    - Toxicidad de grado 3-5 capturada 60 días después de la dosis.
    - Frecuencia de las TLD en los 28 días siguientes a la perfusión de AUTO4.
    - Respuesta global en los meses 1, 3, 6, 9, 12, 15, 18 y 24 tras la perfusión de AUTO4.
    E.5.2Secondary end point(s)
    Frequency and severity of all AEs and SAEs
    Incidence and severity of opportunistic infections following AUTO4 infusion.
    Proportion of patients (who are TRBC1 positive and undergo leukapheresis), for whom an AUTO4 product can be generated (feasibility).
    Determine the CR rate following treatment with AUTO4.
    Evaluate clinical outcomes including DOR, DFS, PFS, OS, time to response (PR+CR) and time to CR.
    RQR8/aTRBC1-CAR positive T cells as determined by PCR and/or flow cytometry at a range of time points in the peripheral blood.
    Enumeration of circulating TRBC1 positive T cells assessed by flow cytometry at a range of time points in the peripheral blood.
    Frecuencia y gravedad de todos los AA y AAG.
    Incidencia y gravedad de las infecciones oportunistas tras la perfusión de AUTO4.
    Proporción de pacientes (que son TRBC1 positivos y se someten a leucaféresis) para quienes se puede generar el medicamento AUTO4 (factibilidad).
    Determinar la tasa de RC tras el tratamiento con AUTO4.
    Evaluar los resultados clínicos, incluidos la duración de la respuesta, la supervivencia libre de enfermedad, la supervivencia libre de progresión, la supervivencia global, el tiempo hasta respuesta (RP + RC) y el tiempo hasta la RC.
    Linfocitos T RQR8/CAR aTRBC1 positivos determinados por reacción en cadena de la polimerasa (PCR) y/o citometría de flujo en diversos puntos temporales en sangre periférica.
    Recuento de linfocitos T TRBC1 positivos circulantes determinado por citometría de flujo en diversos puntos temporales en sangre periférica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety endpoints and AUTO4 monitoring evaluations will be conducted
    throughout the study
    Feasibility to generate AUTO4 assessed after manufacture
    Objective response post AUTO4 infusion
    Duration of response from first observation of complete or partial response to progression, relapse or death
    Disease free survival from first observation of complete response to progression or relapse or death
    Progression free and overall survival measured from first AUTO4 treatment to relapse/disease progression and death, respectively
    biomarker measurements taken at pre-defined protocol schedule.
    Se evaluarán los criterios de valoración de seguridad y de supervisión de AUTO4 durante el estudio.
    Factibilidad de generar AUTO4 evaluada tras la elaboración.
    Respuesta objetiva tras la perfusión de AUTO4.
    Duración de la respuesta de la primera observación de respuesta completa o parcial a la progresión, la recidiva o la muerte.
    Supervivencia libre de enfermedad desde la primera observación de respuesta completa hasta la progresión, la recidiva o la muerte.
    Supervivencia libre de progresión y supervivencia global desde el primer tratamiento con AUTO4 hasta la progresión de la enfermedad/recidiva y la muerte, respectivamente.
    Determinaciones de biomarcadores realizadas según calendario de protocolo.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    The end of the trial will be 24 months after the last patient has received AUTO4 infusion (or earlier, if appropriate).
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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 be eligible to be followed up for up to 15 years post AUTO4 infusion on a separate long-term follow-up protocol. Otherwise, they would be treated per their physician's guidance for their disease treatment.
    Los pacientes serán elegibles para realizar un seguimiento de hasta 15 años después de la infusión de AUTO4 en un protocolo aparte de seguimiento a largo plazo. De lo contrario, serían tratados según las indicaciones de su médico para el tratamiento de la enfermedad.
    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 Decision2020-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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