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    Summary
    EudraCT Number:2019-001073-86
    Sponsor's Protocol Code Number:MT-3724_NHL_001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-08-09
    Trial results View 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 number2019-001073-86
    A.3Full title of the trial
    Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients with Relapsed or Refractory DLBCL
    Seguridad, farmacodinámica y eficacia de MT-3724 en el tratamiento de pacientes con linfoma difuso de células B grandes (LDCBG) recidivante o resistente al tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MT-3724 investigational drug for the treatment of patients with resistant or recurring B-cell cancer
    Un estudio del fármaco en investigación MT-3724 para el tratamiento de pacientes con cáncer de células B resistente o recurrente.
    A.4.1Sponsor's protocol code numberMT-3724_NHL_001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02361346
    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 SponsorMolecular Templates, Inc.
    B.1.3.4CountryUnited States
    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 supportMolecular Templates, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMolecular Templates, Inc.
    B.5.2Functional name of contact pointCorporate Headquarters
    B.5.3 Address:
    B.5.3.1Street Address9301 Amberglen Blvd, Suite 100
    B.5.3.2Town/ cityAustin
    B.5.3.3Post codeTX 78729
    B.5.3.4CountryUnited States
    B.5.6E-mailinfo@MTEM.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.3.2Product code MT-3724
    D.3.4Pharmaceutical form Concentrate for solution 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 codeMT-3724
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 Yes
    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
    relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
    Linfoma difuso de células B grandes (LDCBG) recidivante o resistente.
    E.1.1.1Medical condition in easily understood language
    relapsed or refractory lymphoma
    Linfoma recidivante o resistente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In Part 3 of this study, up to 100 subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) will be treated with 50 μg/kg/dose of MT-3724, and the primary objective will be to:
    Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC (lymphoma response to immunomodulatory therapy criteria) hereinafter referred to as “revised Lugano Criteria” (Cheson et al, 2014, 2016).
    Overall response rate is defined as the proportion of subjects with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review.
    En la parte 3 de este estudio, hasta 100 pacientes con linfoma difuso de células B grandes (LDCBG) recidivante o resistente al tratamiento recibirán 50 μg/kg/dosis de MT-3724 y el objetivo principal será:
    Determinar la eficacia de MT-3724 en monoterapia en pacientes con LDCBG recidivante o resistente al tratamiento de acuerdo con la tasa de respuesta global (TRG) según la clasificación revisada de Lugano para el linfoma, ajustada en función de los criterios de respuesta del linfoma al tratamiento inmunomodulador (CRLTI) (en adelante, "criterios revisados de Lugano") (Cheson et al, 2014, 2016).
    La tasa de respuesta global (TRG) se define como la proporción de pacientes que alcancen una respuesta completa (RC) o una respuesta parcial (RP) de acuerdo con una revisión centralizada independiente que se realizará de forma enmascarada.
    E.2.2Secondary objectives of the trial
    Safety
    Efficacy based on the
    - overall response rate (ORR) defined as the proportion of subjects with either a CR or a PR as determined by investigator assessment.
    - duration of tumor response (DOR): Time from initial documentation of tumor response (PR or CR) to disease progression
    - disease control rate (DCR): Percentage of subjects who have achieved CR, PR and SD (defined as SD for 3 months or longer).
    - progression-free survival (PFS). PFS is defined as the time from study enrollment to the earliest date of disease progression or death from any cause.
    - overall survival (OS). Overall survival is defined as the time from study enrollment to death from any cause
    Pharmacokinetics (PK)
    Pharmacodynamics (PD)
    Immunogenicity: anti-drug antibodies (ADA)
    Quality of life

    Exploratory Objectives:
    Immunogenicity: Neutralizing antibodies (NA)
    Seguridad
    Eficacia, de acuerdo con:
    - la tasa de respuesta global (TRG): la proporción de pacientes que alcancen una RC o una RP de acuerdo con el criterio del investigador.
    - la duración de la respuesta tumoral (DdR): Tiempo transcurrido desde la documentación inicial de la respuesta tumoral (RP o RC) hasta la progresión de la enfermedad.
    - La tasa de control de la enfermedad (TCE): Porcentaje de pacientes que hayan alcanzado una RC, una RP o EE (esto es, "EE" al menos durante 3 meses).
    - Supervivencia sin progresión (SSP): Tiempo transcurrido desde el reclutamiento en el estudio hasta la progresión de la enfermedad o la muerte por cualquier causa (lo que acontezca antes).
    - Supervivencia global [SG]: Tiempo transcurrido desde el reclutamiento en el estudio hasta la muerte por cualquier causa.
    Farmacocinética (FC)
    Farmacodinámica (FD)
    Inmunogenicidad: anticuerpos antifármaco (AAF)
    Calidad de vida

    Objetivos exploratorios:
    Inmunogenicidad: anticuerpos neutralizantes (AN)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects must have relapsed or refractory DLBCL
    - Subjects must have received at least 2 standard of care regimens for NHL treatment
    - Subjects must have life expectancy of >3 months from the start of treatment
    - Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    - Subjects must not be pregnant or plan to become pregnant during the study until the post-study Follow-up Visit
    - Los pacientes deben presentar al menos un diagnóstico de LDCBG
    .- Los pacientes deben haber recibido al menos 2 tratamientos de referencia para el LNH.
    - Los patientes deben tener una esperanza de vida >3 meses desde el inicio del tratamiento.
    - Los pacientes deben tener categoría funcional de 0-2 en la escala del Eastern Cooperative Oncology Group (ECOG).
    - Los sujetos no deben estar embarazados o planear quedar embarazados durante el estudio hasta la visita de seguimiento posterior al estudio
    E.4Principal exclusion criteria
    - Received anti-CD20 MAb within 84 days before the start of treatment
    - Subjects who have received anti-CD20 Mab must have levels below a specified threshold to be eligible for study participation
    - Received approved or investigational treatment for NHL, including radiation therapy to target tumor lesions within 4 weeks, before the start of treatment
    - Received systemic immunosuppressive agents (except prescribed corticosteroids at doses =<20 mg/day prednisone equivalent) within 2 weeks before the start of treatment
    - Received any vaccines except injectable flu vaccine (inactivated or recombinant) within 4 weeks before the start of treatment
    - Received allogeneic stem cell transplant
    - Evidence of seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (positive for hepatitis B surface antigen (HBsAg) or anti-HBsAg and anti-HBcAg antibodies) or hepatitis C virus (positive for anti-HCV antibody or HCV-RCV-RNA quantitation) at screening
    - History of cardiovascular, renal, hepatic or any other disease within 3 months before the start of treatment that in the investigator’s opinion, may increase the risks associated with study participation or require treatments that may interfere with the conduct of the study or the interpretation of study results
    - History of another primary malignancy within the past 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ)
    - Current evidence of new or growing brain or spinal metastases during screening
    - Haber recibido cualquier cantidad de AcM anti-CD20 dentro de los 84 días anteriores al inicio del tratamiento
    - Los sujetos que hayan recibido los AcM anti-CD20 deben tener niveles por debajo de un umbral específico para poder participar en el estudio.
    - Haber recibido un tratamiento autorizado o en investigación para el LNH Incluyendo radioterapia para tratar lesiones tumorales dentro de las 4 semanas anteriores al inicio del tratamiento.
    - Haber recibido fármacos inmunodepresores sistémicos (salvo corticoesteroides con receta en una dosis equivalente a =<20 mg/día de prednisona) en el transcurso de las 2 semanas anteriores al inicio del tratamiento.
    - Haber recibido cualquier vacuna salvo la vacuna inyectable para la gripe (inactivada o recombinante) en el transcurso de las 4 semanas anteriores al inicio del tratamiento.
    - Haber recibido un alotrasplante de células madre.
    - Presentar durante la selección signos de seropositividad para el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis B (resultados positivos en la prueba del antígeno de superficie de la hepatitis B [HBsAg] o presencia de anticuerpos anti-HBsAg y anti-HBcAg) o el virus de la hepatitis C (presencia de anticuerpos anti-VHC o cuantificación de ARN del VHC).
    - Antecedentes de enfermedad cardiovascular, renal, hepática o de otro tipo en el transcurso de los 3 meses anteriores al inicio del tratamiento que, según el criterio del investigador, pueda aumentar los riesgos relacionados con la participación en el estudio o requerir tratamientos que puedan interferir en el desarrollo del estudio o en la interpretación de sus resultados.
    - Presencia durante la selección de signos de metástasis medulares o cerebrales nuevas o en crecimiento.
    E.5 End points
    E.5.1Primary end point(s)
    Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL
    Determinar la eficacia de MT-3724 en monoterapia en pacientes con LDCBG recidivante o resistente al tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    10-14 days following last dose
    10-14 días después de la última dosis
    E.5.2Secondary end point(s)
    - Short-term Safety Follow Up
    - Long-term Safety Follow Up
    - Progression-free survival (PFS)
    - Overall survival (OS)
    - Duration of tumor response (DOR)
    - Seguimiento de la seguridad a corto plazo
    - Seguimiento de la seguridad a largo plazo
    - Supervivencia sin progresión (SSP)
    - Supervivencia global [SG]
    - Duración de la respuesta tumoral (DdR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Short-term Safety Follow Up: 30 days (+/-3) after last dose of MT-3724
    - Long-term Safety Follow Up: Every 6 months (+/-14 days) after the last dose of MT-3724 until death or loss to follow up
    - Progression-free survival (PFS): Time from study enrollment to the earliest date of disease progression or death from any cause
    - Overall survival (OS): Time from study enrollment to death from any cause
    - Duration of tumor response (DOR): Time from initial documentation of tumor response (CR or PR) to disease progression
    - Seguimiento de la seguridad a corto plazo: 30 días (+/-3) después de la última dosis de MT-3724
    - Seguimiento de la seguridad a largo plazo: cada 6 meses (+/- 14 días) después de la última dosis de MT-3724 hasta la muerte o pérdida durante el seguimiento
    - Supervivencia sin progresión (SSP): Tiempo transcurrido desde el reclutamiento en el estudio hasta la progresión de la enfermedad o la muerte por cualquier causa (lo que acontezca antes).
    - Supervivencia global [SG]: Tiempo transcurrido desde el reclutamiento en el estudio hasta la muerte por cualquier causa
    - Duración de la respuesta tumoral (DdR): Tiempo transcurrido desde la documentación inicial de la respuesta tumoral (RP o RC) hasta la progresión de la enfermedad
    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 Yes
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Canada
    Georgia
    Israel
    Italy
    Mexico
    Moldova, Republic of
    Poland
    Romania
    Serbia
    Spain
    Ukraine
    United Kingdom
    United States
    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 del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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)
    Standard of care
    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 Decision2020-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-04-14
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