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    Summary
    EudraCT Number:2018-004888-31
    Sponsor's Protocol Code Number:208750
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-22
    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 number2018-004888-31
    A.3Full title of the trial
    Long Term Follow-Up of Participants Exposed to GSK3377794 (NYESO- 1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor
    Follow-up a lungo termine dei partecipanti esposti a GSK3377794 (NY-ESO-1C259.T), cellule T geneticamente modificate per esprimere un recettore NY-ESO-1 specifico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long Term Follow-Up of Participants Exposed to GSK3377794
    Follow-up a lungo termine dei soggetti esposti a GSK3377794
    A.3.2Name or abbreviated title of the trial where available
    PH1, Long Term Follow-up of Cancer Patients Exposed to NY-ESO-1c259 T
    Follow-up a lungo termine dei soggetti esposti a GSK3377794
    A.4.1Sponsor's protocol code number208750
    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 SponsorGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00448007839733
    B.5.5Fax number000000
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 namena
    D.3.2Product code [GSK3377794]
    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.3.9.2Current sponsor codeGSK3377794
    D.3.9.3Other descriptive nameNY-ESO-1c259T
    D.3.9.4EV Substance CodeSUB185001
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms billion organisms
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 8
    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) No
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product Yes
    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
    Synovial sarcoma
    Sarcoma sinoviale
    E.1.1.1Medical condition in easily understood language
    Synovial sarcoma
    Sarcoma sinoviale
    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 PT
    E.1.2Classification code 10042863
    E.1.2Term Synovial sarcoma
    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
    To monitor participants for delayed AEs associated with administration of autologous cells that have been genetically modified by lentiviral vectors.
    Monitorare i pazienti per rilevare AE ritardati associati alla somministrazione di cellule autologhe che sono state modificate geneticamente mediante vettori lentivirali.
    E.2.2Secondary objectives of the trial
    - To monitor Replication Competent Lentivirus (RCL)
    - To measure persistence of genetically modified cells in the body
    - Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by polymerase chain reaction (PCR)
    - To monitor survival status
    - Monitorare la presenza di lentivirus competenti per la replicazione (RCL)
    - Misurare la persistenza di cellule geneticamente modificate nell’organismo
    - Valutare il pattern dei siti di integrazione del vettore se almeno l’1% delle cellule nel campione surrogato risulta positiva alle sequenze del vettore all’esame della reazione a catena della polimerasi (PCR)
    - Monitorare lo stato di sopravvivenza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type of Participant and Disease Characteristics
    1. Participants who:
    a. Have received at least one dose of GSK3377794 in the interventional study and
    b. Have either completed the interventional study or have withdrawn from it
    Participants who complete the interventional study will complete the assessments
    outlined in the interventional protocol prior to starting on this study.
    Sex
    2. Male or Female participants. Contraceptive use by men or women should be
    consistent with local regulations regarding the methods of contraception for those
    participating in clinical studies.
    a. Male Participants:
    Male participants are eligible to participate if they agree to the following contraception guidelines, starting at the first dose of chemotherapy and for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/gene modified cells in the participant’s blood, whichever is longer. If participants have received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells.
    - Refrain from donating sperm
    PLUS either:
    - Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
    OR
    - Must agree to use contraception/barrier as detailed below
    o Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
    o Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person
    b. Female Participants:
    A female participant is eligible to participate if at least one of the following
    conditions applies:
    - Is not a woman of childbearing potential (WOCBP) as defined in Section 10.4.1 of the protocol
    OR
    - Is a WOCBP (as defined in Section 10.4.1) who will agree to use a barrier method
    (male condom) and use a contraceptive method that is highly effective (with a
    failure rate of <1% per year), as described in Section 10.4.2 for at least 12 months
    after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the participant’s blood, whichever is longer. If WOCBP participants have received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells. WOCBP should also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method.
    - Additional requirements for pregnancy testing are located in Appendix 2
    - The investigator is responsible for review of medical history, menstrual history,
    and recent sexual activity to decrease the risk for inclusion in the interventional
    study of a woman with an early undetected pregnancy
    Informed Consent
    3. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. The informed consent form to participate to the LTFU study will be collected prior to entry into this LTFU protocol and if possible during the conduct of the parent interventional study.
    1. Pazienti che:
    a. Hanno ricevuto almeno una dose di GSK3377794 nello studio interventistico E
    b. Hanno completato o si sono ritirati dallo studio interventistico
    2. Pazienti di entrambi i sessi. L’uso di misure contraccettive da parte dei pazienti di entrambi i sessi deve essere in linea con le normative locali in materia di contraccezione per i partecipanti a studi clinici.
    a. Pazienti di sesso maschile:
    sono eleggibili se acconsentono a seguire le linee guida di contraccezione riportate di seguito, dalla prima dose di chemioterapia e per almeno 12 mesi dopo aver ricevuto l’infusione di cellule T, oppure 4 mesi dopo oppure per 4 mesi dopo aver accertato che non vi sia persistenza di cellule geneticamente modificate nel sangue del partecipante, a seconda di quale dei due periodi è più lungo. Se i partecipanti hanno ricevuto pembrolizumab durante lo studio interventistico, devono utilizzare metodi contraccettivi efficaci per almeno 4 mesi dopo l’ultima dose di pembrolizumab se questo lasso di tempo è superiore alla durata della contraccezione richiesta nel contesto della chemioterapia e della somministrazione di cellule geneticamente modificate.
    • Non donare sperma.
    E INOLTRE:
    • Essere astinenti da rapporti eterosessuali o omosessuali come stile di vita preferito e abituale (astinenza a lungo termine e persistente) e accettare di continuare ad astenersi.
    OPPURE
    • Acconsentire all’uso di un metodo contraccettivo/metodo di barriera descritto qui di seguito:
    o acconsentire a utilizzare un preservativo maschile ed essere informati del beneficio per la partner femminile di usare un metodo contraccettivo altamente efficace in quanto il preservativo potrebbe rompersi o perdere durante il rapporto sessuale con una donna in età fertile non in stato di gravidanza;
    o acconsentire a utilizzare un preservativo maschile in qualsiasi attività che consenta il passaggio di eiaculato a un’altra persona.
    b. Pazienti di sesso femminile:
    sono eleggibili se almeno una delle condizioni indicate di seguito risulta applicabile:
    • non si tratta di una donna in età fertile (WOCBP, woman of childbearing potential) secondo la definizione riportata nella sezione 10.4.1 del protocollo;
    OPPURE
    • E’ una WOCBP e acconsente a utilizzare un metodo di barriera (preservativo maschile) e un metodo contraccettivo altamente efficace (con un tasso di fallimento < 1% l’anno), come illustrato nel paragrafo 10.4.2 del protocollo per almeno 12 mesi dopo aver ricevuto l’infusione di cellule T, oppure per 4 mesi dopo aver accertato che non vi sia persistenza di cellule geneticamente modificate nel sangue del partecipante, a seconda di quale dei due periodi è più lungo. Se le pazienti WOCBP hanno ricevuto pembrolizumab durante lo studio interventistico, devono utilizzare metodi contraccettivi efficaci per almeno 4 mesi dopo l’ultima dose di pembrolizumab se questo lasso di tempo è superiore alla durata della contraccezione richiesta nel contesto della chemioterapia e della somministrazione di cellule geneticamente modificate. Le donne in età fertile devono inoltre acconsentire a non donare ovuli (ovociti) a scopi riproduttivi durante questo periodo. Lo sperimentatore deve valutare l’efficacia del metodo contraccettivo.
    • Ulteriori requisiti relativi alla gravidanza sono riportati nell’Appendice 2 del protocollo.
    • Lo sperimentatore è responsabile della raccolta di anamnesi, anamnesi mestruale e attività sessuale recente per ridurre il rischio di inclusione nello studio interventistico di una donna con una gravidanza non ancora individuata perché in fase precoce.
    3. Capacità di firmare un consenso informato secondo quanto riportato nell’Appendice 1 del protocollo, inclusa l’adesione ai requisiti e alle limitazioni elencate nel modulo di consenso informato e in questo protocollo. Il consenso per partecipare allo studio LTFU sarà raccolto prima dell’ingresso in questo protocollo LTFU e se possibile durante la conduzione dello studio interventistico principale.
    E.4Principal exclusion criteria
    Not applicable
    Non applicabile
    E.5 End points
    E.5.1Primary end point(s)
    AEs to be reported:
    - New malignancies
    - New incidence or exacerbation of a pre-existing neurologic disorder
    - New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
    - New incidence of immune-related hematologic disorder
    - Serious infections (including opportunistic)
    - Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
    AE da segnalare:
    • Nuove neoplasie maligne
    • Nuova incidenza o riacutizzazione di un disturbo neurologico preesistente
    • Nuova incidenza o riacutizzazione di un disturbo reumatologico o di un disturbo autoimmune di altro tipo preesistente
    • Nuova incidenza di un disturbo ematologico immuno-correlato
    • Infezioni gravi (incluse quelle opportunistiche)
    • Patologie e/o ricovero ospedaliero imprevisti, ritenuti correlati alla terapia con cellule geneticamente modificate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Year 1(3, 6 and 12 months), Year 2 (18, 24 months), Year 3 (30 and 36 months), Year 4 (42, 48 months), Year 5 (54, 60 months) and Year 6-15 (annually)
    Anno 1 (3, 6 e 12 mesi dopo aver ricevuto il farmaco sperimentale nello studio principale), anno 2 (18, 24 mesi dopo aver ricevuto il farmaco sperimentale nello studio principale), anno 3 (30 e 36 mesi dopo aver ricevuto il farmaco sperimentale nello studio principale), anno 4 (42 e 48 mesi dopo aver ricevuto il farmaco sperimentale nello studio principale), anno 5 (54 e 60 mesi dopo aver ricevuto il farmaco sperimentale nello studio principale) e anno 6-15 (annuale)
    E.5.2Secondary end point(s)
    - Vesicular Stomatitis Virus G protein (VSV-G) DNA copies in peripheral blood samples
    - Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples
    - Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) identified in peripheral blood
    - Incidence of death and time to death
    - Presenza di copie di DNA (acido desossiribonucleico) della proteina G del virus della stomatite vescicolare (VSV-G) in campioni di sangue periferico
    - Presenza dell’elemento regolatorio post-trascrizionale del virus dell’epatite della marmotta (WPRE) o copie di DNA Psi in campioni di sangue periferico
    - Sequenze del vettore integrate e pattern di integrazione del vettore (per es. policlonale, oligoclonale o monoclonale) identificate nel sangue periferico
    - Incidenza di decessi e tempo al decesso
    E.5.2.1Timepoint(s) of evaluation of this end point
    VSV-G: Year 1 (3, 6 and 12 months), Year 2 (24 months), Year 3 (36 months), Year 4 (48 months), Year 5 (60 months) and Year 6-15 (annually)
    Persistence and Integration: Year 1(3, 6 and 12 months), Year 2(18, 24 months), Year 3 (30 and 36 months), Year 4 (42, 48 months), Year 5 (54, 60 months) and Year 6-15 (annually)
    Survival Status: Year 1 (3, 6 and 12 months), Year 2 (24 months), Year 3 (36 months), Year 4 (48 months), Year 5 (60 months) and Year 6-15 (annually)
    VSV-G: anno 1 (3, 6 e 12 mesi), anno 2 (24 mesi), anno 3 (36 mesi), anno 4 (48 mesi), anno 5 (60 mesi) e anno 6-15 anno (annualmente)
    Persistenza e integrazione: anno 1 (3, 6 e 12 mesi), anno 2 (18, 24 mesi), anno 3 (30 e 36 mesi), anno 4 (42, 48 mesi), anno 5 (54, 60 mesi) e anno 6-15 (annualmente)
    Stato di sopravvivenza: anno 1 (3, 6 e 12 mesi), anno 2 (24 mesi), anno 3 (36 mesi), anno 4 (48 mesi), anno 5 (60 mesi) e anno 6-15 anno (annualmente)
    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
    Studio in aperto - Studio di follow-up a lungo termine in pazienti trattati con GSK3377794 (NYESO- 1
    Open study - Long Term Follow-Up of Participants Exposed to GSK3377794 (NYESO- 1c259T)
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 EEA7
    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
    Canada
    United States
    France
    Germany
    Italy
    Netherlands
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    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 years15
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    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) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 65
    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)
    This LTFU protocol is designed in adherence with Food and Drug Administration (FDA), European Medicines Agency (EMEA) and United States National Institute of Health (NIH) guidelines for long term follow up of participants in gene therapy clinical trials, and involves up to 15 years of monitoring of participants who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies.
    Questo protocollo di LTFU segue le linee guida dell’Agenzia americana Food and Drug Administration (FDA), dell’Agenzia europea per i medicinali (EMA) e del National Institutes of Health (NIH) relative al follow-up a lungo termine di pazienti coinvolti in sperimentazioni cliniche su terapie geniche. Il protocollo prevede un massimo di 15 anni di monitoraggio di pazienti che sono stati esposti a trasferimento genico mediato da lentivirus in studi clinici di GSK.
    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 Decision2020-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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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