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    Clinical Trial Results:
    Dual Vaccine Trial in Myeloproliferative Neoplasms

    Summary
    EudraCT number
    		 2019-001434-34
    Trial protocol
    		 DK  
    Global end of trial date
    28 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Sep 2023
    First version publication date
    24 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MPN19H2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    National Center for cancer immunetherapy
    Sponsor organisation address
    Borgmester Ib Juuls Vej 13, herlev, Denmark, 2730
    Public contact
    Jacob Grauslund, Center for cancer immunetherapy, Dept. of Hematology, Herlev hospital, +45 38688961,
    Scientific contact
    Jacob Grauslund, Center for cancer immunetherapy, Dept. of Hematology, Herlev hospital, +45 38688961,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We will conduct a phase I-II study in patients with mutated MPN by vaccinating with PD-L1 and ARGLong2 peptides with Montanide ISA-51 (Seppic Inc., Paris, France) as adjuvant, to monitor the immunological response to vaccination and subsequently safety and toxicity.
    Protection of trial subjects
    Yes according to EU and Danish law. All participants provided written informed consent before trial enrollment. The protocol was approved by the Ethics Committee of the Capital Region of Denmark, the National Board of Health, and the Danish Data Protection Agency, and it was registered at https://www. clinicaltrials.gov (NCT04051307; date of registration: August 9, 2019).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    8
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 9
    Number of subjects completed
    		 9

    Period 1
    Period 1 title
    intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Arglong2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for emulsion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients were vaccinated with 200 µg of ArgLong2 (ARG1169-206), a 38-aa peptide (ISAKDIVYIGLRDVDPGEHYILKTLGI KYFSMTEVDRL),

    Investigational medicinal product name
    PD-L1Long1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for emulsion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 µg of PD-L1Long1 (PD-L119-27), a 19-aa peptide (FMTYWHLLNAFTVTVPKDL)

    Number of subjects in period 1
    		intervention
    Started
    9
    Completed
    9

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 -

    Subject analysis set title
    trial cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    trial cohort

    Primary: immune response

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    End point title
    		 immune response [1]
    End point description
    Immune responses were evaluated with in vitro and ex vivo IFN-g ELISPOT assays
    End point type
    Primary
    End point timeframe
    from baseline to end of trial
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All patients showed clear responses, it has little or no effect showing that 100% had a response. see the article. https://www.frontiersin.org/articles/10.3389/fimmu.2023.1117466/full
    End point values
    		 trial cohort
    Number of subjects analysed
    9
    Units: yes or no
    9
    Attachments
    		 In vitro
    ex vivo
    No statistical analyses for this end point

    Secondary: clinical response

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    End point title
    		 clinical response
    End point description
    To evaluate clinical responses, we applied the response criteria for PV and ET. (Barosi G, Mesa R, Finazzi G, Harrison C, Kiladjian JJ, Lengfelder E, et al. Revised response criteria for polycythemia vera and essential thrombocythemia: An ELN and IWG-MRT consensus project. Blood (2013) 121:4778–81. doi: 10.1182/blood-2013-01- 47889.)
    End point type
    Secondary
    End point timeframe
    from baseline to end of trial
    End point values
    		 trial cohort
    Number of subjects analysed
    9
    Units: yes or no
    9
    Attachments
    		 blood samples
    allele burden
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline to end of trial.
    Adverse event reporting additional description
    Patients were evaluated according to CTCAE ver. 5.0 at every consultation/or visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 -

    Serious adverse events
    		 intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    vasovagal reaction
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nervous system disorders
    head ache
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    edema
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Immune system disorders
    flu like symptoms
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Vaccination site reaction
         subjects affected / exposed
    9 / 9 (100.00%)
         occurrences all number
    9
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Product issues
    body odor
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Infection
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Fatigue
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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