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    Summary
    EudraCT Number:2017-002139-41
    Sponsor's Protocol Code Number:R1979-ONC-1625
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002139-41
    A.3Full title of the trial
    An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an anti CD20 x anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Follicular Lymphoma
    Studio in aperto per valutare l’attività antitumorale e la sicurezza di REGN1979, un anticorpo bispecifico ANTI-CD20 X ANTI-CD3, in pazienti con linfoma follicolare recidivante o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Anti-Tumor Activity and Safety of REGN1979 in patients with Follicular Lymphoma that has been previously treated
    Studio per valutare l'attività antitumorale e la sicurezza di REGN1979 in pazienti con linfoma follicolare precedentemente trattati
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberR1979-ONC-1625
    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 SponsorREGENERON PHARMACEUTICALS, 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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailclinicaltrials@regeneron.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 nameREGN1979
    D.3.2Product code [REGN1979]
    D.3.4Pharmaceutical form Concentrate for solution 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.3.9.2Current sponsor codeREGN1979
    D.3.9.4EV Substance CodeSUB179367
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Follicular lymphoma
    Linfoma follicolare
    E.1.1.1Medical condition in easily understood language
    Cancer (Follicular lymphoma)
    Cancro (linfoma follicolare)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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
    The primary objective of this study is to assess the anti-tumor activity of single agent REGN1979, as measured by objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma by independent central review, in patients with relapsed or refractory follicular lymphoma (FL) previously treated with at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
    L’obiettivo primario di questo studio è valutare l’attività antitumorale di REGN1979 in monoterapia, misurata in base al tasso di risposta obiettiva (ORR) secondo la Classificazione di Lugano della risposta nel linfoma maligno da parte di una revisione centrale indipendente, in pazienti con linfoma follicolare (LF) recidivante o refrattario precedentemente trattati con almeno 2 precedenti linee di terapia sistemica, inclusi un anticorpo anti-CD20 e un agente alchilante.
    E.2.2Secondary objectives of the trial
    The secondary objectives include:
    • To assess the anti-tumor activity of single agent REGN1979 in patients with relapsed or refractory FL, as measured by:
    o ORR according to the Lugano Classification (Cheson, 2014)
    o Complete response (CR) rate according to the Lugano Classification
    o Progression free survival (PFS) according to Lugano Classification
    o Overall survival (OS)
    Gli obiettivi secondari di questo studio sono:
    - Valutare l’attività antitumorale di REGN1979 in monoterapia in pazienti con LF recidivante o refrattario, misurata in base a:
    o ORR, valutato secondo la Classificazione di Lugano (Cheson, 2014)
    o Tasso di risposta completa (CR) secondo la Classificazione di Lugano
    o Sopravvivenza libera da progressione (PFS) secondo la Classificazione di Lugano
    o Sopravvivenza globale (OS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Substudy of future biomedical research.v1.1.0 14Mar2019.
    The main goal of this research will be to better understand serious diseases that cause illness and death. The purpose of this research is to:
    • Better understand the causes of different types of diseases and how to diagnose, treat, or prevent them.
    • Determine whether specific biomarkers (molecules found in your blood or tissue) or genes are associated with certain diseases or disorders.
    • Develop new methods for studying different types of diseases.
    Genomics substudy v1.1.0 14Mar2019.
    The purpose of the genomic analyses is to identify genomic associations with clinical or biomarker response, other clinical outcome measures, and possible AEs.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: SOTTOSTUDIO SULLA RICERCA BIOMEDICA FUTURA, v1.1.0 14Mar2019
    L’obiettivo principale di questa ricerca sarà comprendere meglio le gravi patologie che causano malattie e decesso. Lo scopo di questa ricerca è:
    - comprendere meglio le cause dei diversi tipi di malattie e come diagnosticarle, trattarle o prevenirle;
    - determinare se specifici biomarcatori (molecole presenti nel Suo sangue o tessuto) o geni sono associati a determinate malattie o disturbi; e
    - sviluppare nuovi metodi per studiare diversi tipi di malattie.
    SOTTOSTUDIO GENOMICO v1.1.0 14Mar2019
    Lo scopo delle analisi genomiche è identificare le associazioni genomiche con risposta clinica o biomarker, altre misure di outcome clinico e possibili eventi avversi.
    E.3Principal inclusion criteria
    Principal inclusion in the study are:
    1. Age 18 years or greater
    2. Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
    3. Must have received at least 2 prior lines of therapy, including an anti-CD20 antibody and an alkylating agent.
    4. Measurable disease on cross sectional imaging (defined as at least 1 bi dimensionally measurable nodal lesion of =1.5 cm in the greatest transverse diameter (GTD) regardless of the short axis diameter) documented by diagnostic imaging (computed tomography [CT], or magnetic resonance imaging [MRI]).
    5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or1.
    6. Adequate bone marrow function as documented by:
    a. Platelet count =50 x 109/L. A patient may not have received platelet transfusion within 7 days prior to first dose of REGN1979 in order to meet the platelet eligibility criterion.
    b. Hemoglobin =9.0 g/dL
    c. Absolute neutrophil count (ANC) =1.0 x 109/L. A patient may not have received granulocyte colony stimulating factor within 2 days prior to first dose of REGN1979 in order to meet the ANC eligibility criterion.
    7. Adequate hepatic function
    Pricipali criteri di inclusione nello studio sono:
    1. Età 18 anni o maggiore
    2. La conferma istopatologica centrale della diagnosi FL da 1 a 3a deve essere ottenuta prima dell'iscrizione allo studio. I pazienti con FL di grado 3b non sono eleggibili. Il sottotipaggio del linfoma follicolare si basa sulla classificazione dell'Organizzazione mondiale della sanità (OMS) (Swerdlow, 2017).
    3. Deve aver ricevuto almeno 2 linee precedenti di terapia, incluso un anticorpo anti-CD20 e un agente alchilante.
    4. Malattia misurabile nell'immagine in sezione trasversale (definita come almeno 1 lesione nodale misurabile dimensionalmente di = 1,5 cm nel diametro trasversale massimo (GTD) indipendentemente dal diametro dell'asse corto) documentata mediante imaging diagnostico (tomografia computerizzata [CT], o risonanza magnetica [MRI]).
    5. Status di prestazione 0 o 1 del gruppo di ECOG.
    6. Funzione adeguata del midollo osseo documentata da:
    a. Conta piastrinica = 50 x 109 / L. Un paziente può non aver ricevuto trasfusione piastrinica entro 7 giorni prima della prima dose di REGN1979 al fine di soddisfare il criterio di ammissibilità piastrinica.
    b. Emoglobina = 9,0 g / dl
    c. Conteggio assoluto dei neutrofili (ANC) = 1,0 x 109 / L. Un paziente può non aver ricevuto un fattore di stimolazione delle colonie di granulociti entro 2 giorni prima della prima dose di REGN1979 al fine di soddisfare il criterio di ammissibilità ANC.
    7. Funzione epatica adeguata
    E.4Principal exclusion criteria
    Principal exclusion criteria are:
    1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
    2. Treatment with any systemic anti lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
    3. History of allogeneic stem cell transplantation
    4. Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
    5. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
    6. History of neurodegenerative condition or CNS movement disorder
    7. Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential
    I principali criteri di esclusione sono:
    1. Linfoma primario del sistema nervoso centrale (SNC) o coinvolgimento noto di NHL non primario del SNC (sospetto di linfoma del CNS deve essere valutato mediante puntura lombare, a seconda dei casi, oltre alla TC obbligatoria o alla RMN obbligatoria).
    2. Terapia con qualsiasi terapia sistemica anti-linfoma entro 5 emivite o entro 28 giorni prima della prima somministrazione del farmaco in studio, a seconda di quale dei due è più breve.
    3. Storia del trapianto di cellule staminali allogeniche
    4. Trattamento precedente con qualsiasi terapia con cellule T del recettore dell'antigene chimerico (CAR-T)
    5. Trattamento continuo con corticosteroidi sistemici con più di 10 mg al giorno di prednisone o equivalente antinfiammatorio entro 72 ore dall'inizio del farmaco in studio
    6. Storia della condizione neurodegenerativa o disturbo del movimento del SNC
    7. Vaccinazione entro 28 giorni prima della somministrazione del farmaco in studio con un vettore con potenziale replicativo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is ORR from first dose until 194 weeks following the first dose, as measured by the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and according to independent central review, in patients with relapsed or refractory FL previously treated with at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
    L’endpoint primario dello studio è l’ORR dalla prima dose fino a 194 settimane dopo la prima dose, misurato secondo la Classificazione di Lugano della risposta nel linfoma maligno (Cheson, 2014) e in base a una revisione centrale indipendente, in pazienti con LF recidivante o refrattario precedentemente trattati con almeno 2 precedenti linee di terapia sistemica, inclusi un anticorpo anti-CD20 e un agente alchilante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    194 weeks
    194 settiamane
    E.5.2Secondary end point(s)
    Secondary endpoints include:
    • ORR according to the Lugano Classification as assessed by local investigator evaluation from first dose up to 194 weeks following the first dose
    • CR rate from first dose until 194 weeks following the first dose, according to the Lugano Classification
    • PFS from first dose until 194 weeks following the first dose, according to the Lugano Classification, as assessed by:
    • OS from first dose up to until 194 weeks following the first dose
    Gli endpoint secondari sono:
    - ORR, valutato secondo la Classificazione di Lugano in base alla valutazione dello Sperimentatore locale dalla prima dose fino a 194 settimane dopo la prima dose
    - Tasso di CR dalla prima dose fino a 194 settimane dopo la prima dose, valutato secondo la Classificazione di Lugano
    - PFS dalla prima dose fino a 194 settimane dopo la prima dose, valutata secondo la Classificazione di Lugano
    - OS dalla prima dose fino a 194 settimane dopo la prima dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    194 weeks
    194 settimane
    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 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) 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 No
    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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Korea, Democratic People's Republic of
    Singapore
    Taiwan
    United States
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 60
    F.4.2.2In the whole clinical trial 112
    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)
    None
    nessuno
    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 Decision2019-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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