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    Clinical Trial Results:
    Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

    Summary
    EudraCT number
    		 2020-000722-26
    Trial protocol
    		 SE   FR   IT  
    Global end of trial date
    30 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2024
    First version publication date
    04 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3AVM-003-HC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04390113
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AlloVir, Inc.
    Sponsor organisation address
    1100 Winter Street, Waltham, MA, United States, 02451
    Public contact
    Clinical Trials Information Line, AlloVir, Inc., +1 (833)409-2281, clinicaltrials@allovir.com
    Scientific contact
    Clinical Trials Information Line, AlloVir, Inc., +1 (833)409-2281, clinicaltrials@allovir.com
    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
    30 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the time to resolution of macroscopic hematuria in recipients of posoleucel (PSL) to that in recipients of placebo.
    Protection of trial subjects
    This study was performed in compliance with the principles of Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Mar 2021
    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
    Canada: 2
    Country: Number of subjects enrolled
    United States: 61
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Italy: 9
    Worldwide total number of subjects
    97
    EEA total number of subjects
    18
    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)
    2
    Adults (18-64 years)
    95
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled from March 2021 to Jan 2024 across 57 study centers in the United States, Canada, France, Italy, Spain, Sweden, the United Kingdom and South Korea.

    Pre-assignment
    Screening details
    		 Overall 144 participants were screened and a total of 97 participants were randomized in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Posoleucel (ALVR105)
    Arm description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered intravenously (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posoleucel (PSL)
    Investigational medicinal product code
    Other name
    ALVR105, PSL
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells, while who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells. All infusions were administered intravenously (via peripheral or central line) over approximately 5 minutes as a slow push.

    Arm title
    		 Placebo
    Arm description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered IV (via peripheral or central line) over approximately 5 minutes as a slow push.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received weight-based matching placebo to posoleucel. All infusions were administered IV (via peripheral or central line) over approximately 5 minutes as a slow push.

    Number of subjects in period 1
    		Posoleucel (ALVR105) Placebo
    Started
    57
    40
    Completed
    37
    26
    Not completed
    20
    14
         Physician decision
    1
    3
         Consent withdrawn by subject
    10
    5
         Adverse event, non-fatal
    1
    -
         Death
    2
    1
         Other
    1
    -
         Study terminated by sponsor
    5
    3
         Missing
    -
    1
         Not treated
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Posoleucel (ALVR105)
    Reporting group description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered intravenously (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

    Reporting group title
    Placebo
    Reporting group description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered IV (via peripheral or central line) over approximately 5 minutes as a slow push.

    Reporting group values
    		 Posoleucel (ALVR105) Placebo Total
    Number of subjects
    		 57 40 97
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.9 ± 16.59 47.0 ± 16.60 -
    Gender categorical
    Units: Subjects
        Female
    		 19 16 35
        Male
    		 38 24 62
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 13 7 20
        Not Hispanic or Latino
    		 38 30 68
        Unknown or Not Reported
    		 6 3 9
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 7 3 10
        Native Hawaiian or Other Pacific Islander
    		 2 0 2
        Black or African American
    		 9 2 11
        White
    		 33 30 63
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 5 5 10

    End points

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    End points reporting groups
    Reporting group title
    Posoleucel (ALVR105)
    Reporting group description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered intravenously (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

    Reporting group title
    Placebo
    Reporting group description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered IV (via peripheral or central line) over approximately 5 minutes as a slow push.

    Primary: Time to Resolution of Macroscopic Hematuria

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    End point title
    		 Time to Resolution of Macroscopic Hematuria
    End point description
    Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study. BK Intent-to-Treat [ITT] Population: All patients randomized who had BKV in their urine at baseline.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Posoleucel (ALVR105) Placebo
    Number of subjects analysed
    48
    38
    Units: days
        median (confidence interval 95%)
    36 (22.0 to 63.0)
    31 (18.0 to 63.0)
    Statistical analysis title
    		 Primary Analysis: Posoleucel versus Placebo
    Statistical analysis description
    Stratified log rank test p-value for the primary efficacy endpoint is based on the stratification factors at randomization. The stratified Cox model is employed to estimate the hazard ratio and 95% CI. Stratification factors include age (<12 years or >=12 years) and use of cidofovir within 4 weeks prior to screening.
    Comparison groups
    Posoleucel (ALVR105) v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6253
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.55

    Secondary: Time Until Bladder Pain is Resolved

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    End point title
    		 Time Until Bladder Pain is Resolved
    End point description
    End point type
    Secondary
    End point timeframe
    Until event occurrence through Week 24
    End point values
    		 Posoleucel (ALVR105) Placebo
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: days
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [1] - Data not collected due to early study termination.
    [2] - Data not collected due to early study termination.
    No statistical analyses for this end point

    Secondary: Days in the Hospital for Any Reason

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    End point title
    		 Days in the Hospital for Any Reason
    End point description
    End point type
    Secondary
    End point timeframe
    Until event occurrence through Week 24
    End point values
    		 Posoleucel (ALVR105) Placebo
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: days
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [3] - Data not collected due to early study termination.
    [4] - Data not collected due to early study termination.
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)

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    End point title
    		 Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)
    End point description
    Grading of acute GVHD is reported according to CTCAE version 5.0 which ranges from Grade 0 (best/no disease) to. Grade IV (worst). Participants with Grade I-IV are included. Modified ITT Population (mITT): All randomized participants who receive any dose of study drug.
    End point type
    Secondary
    End point timeframe
    Until event occurrence through Week 24
    End point values
    		 Posoleucel (ALVR105) Placebo
    Number of subjects analysed
    57
    39
    Units: Participants
    11
    9
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)

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    End point title
    		 Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)
    End point description
    CRS is defined as a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms can be progressive, must include fever at the onset, and may include hypotension, capillary leak (hypoxia), and end organ dysfunction. mITT: All randomized participants who receive any dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Posoleucel (ALVR105) Placebo
    Number of subjects analysed
    57
    39
    Units: Participants
    1
    0
    No statistical analyses for this end point

    Secondary: Time to Resolution for All Target Viruses

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    End point title
    		 Time to Resolution for All Target Viruses
    End point description
    End point type
    Secondary
    End point timeframe
    Until event occurrence through Week 24
    End point values
    		 Posoleucel (ALVR105) Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: days
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [5] - Data not collected due to early study termination.
    [6] - Data not collected due to early study termination.
    No statistical analyses for this end point

    Secondary: Average Daily Bladder Pain

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    End point title
    		 Average Daily Bladder Pain
    End point description
    End point type
    Secondary
    End point timeframe
    Until event occurrence through Week 6
    End point values
    		 Posoleucel (ALVR105) Placebo
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [7] - Data not collected due to early study termination.
    [8] - Data not collected due to early study termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Posoleucel (ALVR105)
    Reporting group description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×107 PSL cells (or placebo), while who weighed ≥40 kg at the time of screening received 4×107 PSL cells (or placebo). All infusions were administered IV (via peripheral or central line) over approximately 5 minutes as a slow push.

    Reporting group title
    Placebo
    Reporting group description
    		 All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×107 PSL cells (or placebo), while who weighed ≥40 kg at the time of screening received 4×107 PSL cells (or placebo). All infusions were administered IV (via peripheral or central line) over approximately 5 minutes as a slow push.

    Serious adverse events
    		 Posoleucel (ALVR105) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 57 (49.12%)
    19 / 39 (48.72%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arterial revascularisation
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Acute graft versus host disease in intestine
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute graft versus host disease in liver
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic graft versus host disease in intestine
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Painful respiration
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Investigations
    Lipase increased
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion reaction
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant failure
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral haemorrhagic cystitis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial pyelonephritis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Human herpesvirus 6 encephalitis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia escherichia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral haemorrhagic cystitis
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Posoleucel (ALVR105) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 57 (94.74%)
    36 / 39 (92.31%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 39 (5.13%)
         occurrences all number
    2
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 39 (2.56%)
         occurrences all number
    4
    1
    Hypotension
         subjects affected / exposed
    6 / 57 (10.53%)
    4 / 39 (10.26%)
         occurrences all number
    6
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Oedema peripheral
         subjects affected / exposed
    3 / 57 (5.26%)
    4 / 39 (10.26%)
         occurrences all number
    3
    4
    Pyrexia
         subjects affected / exposed
    11 / 57 (19.30%)
    8 / 39 (20.51%)
         occurrences all number
    11
    8
    Immune system disorders
    Acute graft versus host disease in intestine
         subjects affected / exposed
    8 / 57 (14.04%)
    3 / 39 (7.69%)
         occurrences all number
    8
    3
    Acute graft versus host disease in liver
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Acute graft versus host disease in skin
         subjects affected / exposed
    6 / 57 (10.53%)
    5 / 39 (12.82%)
         occurrences all number
    6
    5
    Chronic graft versus host disease in eye
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Chronic graft versus host disease in intestine
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Chronic graft versus host disease in skin
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    3
    3
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Chronic graft versus host disease oral
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 57 (8.77%)
    2 / 39 (5.13%)
         occurrences all number
    5
    2
    Dyspnoea
         subjects affected / exposed
    6 / 57 (10.53%)
    2 / 39 (5.13%)
         occurrences all number
    6
    2
    Hypoxia
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Respiratory failure
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Rhinorrhoea
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 39 (2.56%)
         occurrences all number
    4
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Confusional state
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Depression
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Hallucination
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Insomnia
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    3
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 57 (3.51%)
    4 / 39 (10.26%)
         occurrences all number
    2
    4
    Blood creatinine increased
         subjects affected / exposed
    6 / 57 (10.53%)
    6 / 39 (15.38%)
         occurrences all number
    6
    6
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 57 (1.75%)
    4 / 39 (10.26%)
         occurrences all number
    1
    4
    C-reactive protein increased
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    3
    Neutrophil count decreased
         subjects affected / exposed
    6 / 57 (10.53%)
    5 / 39 (12.82%)
         occurrences all number
    6
    5
    Platelet count decreased
         subjects affected / exposed
    7 / 57 (12.28%)
    3 / 39 (7.69%)
         occurrences all number
    7
    3
    White blood cell count decreased
         subjects affected / exposed
    5 / 57 (8.77%)
    3 / 39 (7.69%)
         occurrences all number
    5
    3
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    Tachycardia
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    3
    Headache
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Dizziness
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 57 (7.02%)
    9 / 39 (23.08%)
         occurrences all number
    4
    9
    Febrile neutropenia
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Neutropenia
         subjects affected / exposed
    6 / 57 (10.53%)
    0 / 39 (0.00%)
         occurrences all number
    6
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 39 (5.13%)
         occurrences all number
    2
    2
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 57 (10.53%)
    7 / 39 (17.95%)
         occurrences all number
    6
    7
    Constipation
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    3
    3
    Diarrhoea
         subjects affected / exposed
    13 / 57 (22.81%)
    8 / 39 (20.51%)
         occurrences all number
    13
    8
    Dry mouth
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 39 (2.56%)
         occurrences all number
    4
    1
    Nausea
         subjects affected / exposed
    11 / 57 (19.30%)
    3 / 39 (7.69%)
         occurrences all number
    11
    3
    Vomiting
         subjects affected / exposed
    7 / 57 (12.28%)
    2 / 39 (5.13%)
         occurrences all number
    7
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 39 (5.13%)
         occurrences all number
    2
    2
    Rash
         subjects affected / exposed
    0 / 57 (0.00%)
    7 / 39 (17.95%)
         occurrences all number
    0
    7
    Rash maculo-papular
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    3
    3
    Dysuria
         subjects affected / exposed
    6 / 57 (10.53%)
    2 / 39 (5.13%)
         occurrences all number
    6
    2
    Haematuria
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 39 (0.00%)
         occurrences all number
    4
    0
    Urinary retention
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 39 (0.00%)
         occurrences all number
    4
    0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Flank pain
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Pain in extremity
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    COVID-19
         subjects affected / exposed
    6 / 57 (10.53%)
    3 / 39 (7.69%)
         occurrences all number
    6
    3
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    3
    3
    Cytomegalovirus viraemia
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    Epstein-Barr virus infection reactivation
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Oral candidiasis
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    3
    3
    Parainfluenzae virus infection
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 39 (5.13%)
         occurrences all number
    2
    2
    Pneumonia
         subjects affected / exposed
    6 / 57 (10.53%)
    4 / 39 (10.26%)
         occurrences all number
    6
    4
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 57 (5.26%)
    5 / 39 (12.82%)
         occurrences all number
    3
    5
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 39 (5.13%)
         occurrences all number
    2
    2
    Viral haemorrhagic cystitis
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 57 (10.53%)
    5 / 39 (12.82%)
         occurrences all number
    6
    5
    Hyperglycaemia
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    3
    Hyperphosphataemia
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Hypocalcaemia
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    3
    0
    Hypokalaemia
         subjects affected / exposed
    9 / 57 (15.79%)
    8 / 39 (20.51%)
         occurrences all number
    9
    8
    Hypomagnesaemia
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Hyponatraemia
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Hypophosphataemia
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    Metabolic acidosis
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2020
    Amendment 1
    12 Nov 2020
    Amendment 2
    17 Jun 2021
    Amendment 3
    23 Feb 2022
    Amendment 4
    13 Nov 2023
    Amendment 5

    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.
    AlloVir decided to discontinue the trial on 22-Dec-2023 following a pre-planned DSMB futility analysis concluding the study was unlikely to meet its primary endpoint; no safety concerns were identified.
    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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