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    Clinical Trial Results:
    T cell therapy for patients with advanced Renal Cell Carcinoma

    Summary
    EudraCT number
    		 2016-001454-18
    Trial protocol
    		 DK  
    Global end of trial date
    31 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2022
    First version publication date
    04 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UG1617
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02926053
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Inge Marie Svane
    Sponsor organisation address
    Borgmester Ib Juuls Vej 25c, Herlev, Denmark, 2730
    Public contact
    Mette Wassard Yde, National Center for Cancer Immune Therapy, 0045 38689339, mette.wassard.yde@regionh.dk
    Scientific contact
    Mette Wassard Yde, National Center for Cancer Immune Therapy, 0045 38689339, mette.wassard.yde@regionh.dk
    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
    31 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate toxicity (according to CTCAE version 4.0) and feasibility.
    Protection of trial subjects
    Standard-of-care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Danish patients with renal cell cancer was included in the period March 2017 - September 2019.

    Pre-assignment
    Screening details
    		 In total eight patients were found eligible. Five patient were included for treatment. Patients was not included due to clinical progression (1) or patient's wish/received other treatment (2).

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

    Arms
    Arm title
    		 All patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tumor-infiltrating lymphocytes
    Investigational medicinal product code
    Other name
    TIL
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    TILs were infused day 0. Maximum number of cultured TILs were infused ranging from 46-96 x 10e9 cells

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Cy
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide 60 mg/kg was administered once daily on day -7 and -6

    Investigational medicinal product name
    Fludarabine phosphate
    Investigational medicinal product code
    Other name
    Fludara
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fludarabine phosphate was administered once daily 25 mg/m2 (max 50 mg) at days -5 to -1

    Investigational medicinal product name
    Interleukin-2
    Investigational medicinal product code
    Other name
    IL-2, aldesleukin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Interleukin-2 was adminstered as an intravenous bolus over 15 minutes at dose 600.000 IE/kg every 8 hours starting from day 0 for a maximum of 15 doses.

    Number of subjects in period 1
    		All patients
    Started
    5
    Completed
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full trial
    Reporting group description
    		 -

    Reporting group values
    		 Full trial Total
    Number of subjects
    		 5 5
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All treated patients

    Subject analysis sets values
    		 Treated patients
    Number of subjects
    5
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    5
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    1
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All treated patients

    Primary: Number of patients in which the treatment was tolerable

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    End point title
    		 Number of patients in which the treatment was tolerable [1]
    End point description
    Number of patients who received treatment according to protocol
    End point type
    Primary
    End point timeframe
    Full 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: In this phase I study, the primary end point is tolerability and there is no appropriate statistical test
    End point values
    		 All patients
    Number of subjects analysed
    5
    Units: patients
    5
    No statistical analyses for this end point

    Secondary: Infusion products with detectable in-vitro anti-tumor responses

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    End point title
    		 Infusion products with detectable in-vitro anti-tumor responses
    End point description
    End point type
    Secondary
    End point timeframe
    Any time after the infusion product has been produced
    End point values
    		 All patients
    Number of subjects analysed
    5
    Units: Infusion products
    4
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Patients who achieved partial or complete response according to RECIST 1.1 criteria
    End point type
    Secondary
    End point timeframe
    Full trial
    End point values
    		 All patients
    Number of subjects analysed
    5
    Units: Patients
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Full trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Treated patients
    Reporting group description
    		 -

    Serious adverse events
    		 Treated patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Hypotension
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treated patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    Nervous system disorders
    Confusional state
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Hallucination
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Pain
         subjects affected / exposed
    4 / 5 (80.00%)
         occurrences all number
    4
    Performance status decreased
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Weight increased
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Petechiae
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    4 / 5 (80.00%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Stomatitis
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    3
    Vomiting
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Melaena
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Dry skin
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    3
    Infections and infestations
    Infection
         subjects affected / exposed
    4 / 5 (80.00%)
         occurrences all number
    4

    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
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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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