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    Clinical Trial Results:
    A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma.

    Summary
    EudraCT number
    2016-003893-42
    Trial protocol
    GB   NL  
    Global end of trial date
    05 Sep 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Sep 2020
    First version publication date
    20 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AUTO2-MM1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03287804
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Autolus Limited
    Sponsor organisation address
    Forest House, 58 Wood Lane, White City, London, United Kingdom, W12 7RZ
    Public contact
    Clinical Project Manager, Autolus Limited, +44 1483 920748, clinicaltrials@autolus.com
    Scientific contact
    Clinical Project Manager, Autolus Limited, +44 1483 920748, clinicaltrials@autolus.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
    01 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Phase 1: Assess the safety and tolerability of AUTO2, identify the recommended Phase II dose and maximum tolerated dose (MTD), where applicable. Phase 2: To evaluate the anti-tumour effect of AUTO2. Long term follow-up is conducted under the separate long term follow-up study protocol AUTO-LT1.
    Protection of trial subjects
    The Investigator was responsible for conducting the study in full accordance with the clinical study protocol, the latest revision of the Declaration of Helsinki, the Good Clinical Practice: Consolidated Guideline, and all applicable national and local laws and regulations for clinical research. Information regarding any investigational sites participating in this study that cannot comply with these standards was documented and appropriate actions taken. For studies conducted in the EU/European Economic Area countries, the Investigator has ensured compliance with the EU Clinical Trial Directive [2001/20/EC]. For studies conducted in the United States or under a United States investigational new drug (IND), the Investigator has additionally ensure adherence to the basic principles of “Good Clinical Practice” as outlined in the current version of 21 Code of Federal Regulations, subchapter D, part 312, “Responsibilities of Sponsor and Investigators”, part 50, “Protection of Human Subjects”, and part 56, “Institutional Review Boards”.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 May 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    15 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    United Kingdom: 11
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    9
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited at two study centres in the United Kingdom and one study centre in the Netherlands.

    Pre-assignment
    Screening details
    Screening procedures were performed up to 12 weeks before study drug was administered.

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

    Arms
    Arm title
    AUTO2
    Arm description
    Relapsed or refractory myeloma subjects.
    Arm type
    Experimental

    Investigational medicinal product name
    AUTO2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a single dose as an intravenous infusion on Day 0.

    Number of subjects in period 1
    AUTO2
    Started
    12
    Received Study Treatment
    11
    Completed
    1
    Not completed
    11
         Progressive disease
    8
         Physician decision
    2
         Death before study treatment
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AUTO2
    Reporting group description
    Relapsed or refractory myeloma subjects.

    Reporting group values
    AUTO2 Total
    Number of subjects
    12 12
    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)
    9 9
        From 65-84 years
    3 3
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    9 9
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0
        Not Hispanic or Latino
    12 12
    Race
    Units: Subjects
        Black/African American
    2 2
        White
    10 10

    End points

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    End points reporting groups
    Reporting group title
    AUTO2
    Reporting group description
    Relapsed or refractory myeloma subjects.

    Primary: Phase 1: Number of Subjects with Grade 3 to 5 Toxicity during the Dose Limiting Toxicity (DLT) Period

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    End point title
    Phase 1: Number of Subjects with Grade 3 to 5 Toxicity during the Dose Limiting Toxicity (DLT) Period [1]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 28 days post-infusion
    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: Only descriptive summary statistics were planned for this endpoint.
    End point values
    AUTO2
    Number of subjects analysed
    11
    Units: Subjects
    0
    No statistical analyses for this end point

    Primary: Phase 1: Number of Subjects with a Dose Limiting Toxicity (DLT)

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    End point title
    Phase 1: Number of Subjects with a Dose Limiting Toxicity (DLT) [2]
    End point description
    Dose limiting toxicity was defined as: Any new non-hematological AE of Grade 3 or higher toxicity using the NCI CTCAE (Version 4.03), which is probably or definitely related to AUTO2 therapy, which occurs within the DLT evaluation period, and which fails to resolve to Grade 2 or better within 14 days, despite appropriate supportive measures; A Grade 4 CRS; Any other reason for activation of the safety switch after receiving AUTO2; Any other fatal event (Grade 5) or life-threatening event (Grade 4) that cannot be managed with conventional supportive measures or which in the opinion of the SEC necessitates dose reduction or other modification to trial treatment to avoid a similar hazard in future patients. Effort should be made to perform an autopsy in case of fatal event where the aetiology is unclear; Any event that in the opinion of treating investigators and/ or Medical Monitor puts the patient at undue risk may also be considered a DLT.
    End point type
    Primary
    End point timeframe
    Up to 28 days post-infusion
    Notes
    [2] - 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: Only descriptive summary statistics were planned for this endpoint.
    End point values
    AUTO2
    Number of subjects analysed
    11
    Units: Subjects
    0
    No statistical analyses for this end point

    Primary: Phase 2: Best Overall Response

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    End point title
    Phase 2: Best Overall Response [3]
    End point description
    The analysis population consisted of all subjects who received at least 1 dose (complete or partial) of AUTO2 therapy in Phase I of the study. No patients were enrolled in Phase II as the study was early terminated in Phase I. Best overall response was defined as stringent complete response + complete response + very good partial response + partial response following treatment with AUTO2. Response Criteria Per IMWG Consensus Recommendations
    End point type
    Primary
    End point timeframe
    Up to 2 years
    Notes
    [3] - 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: Statistical analysis was not performed on this endpoint as the study was early terminated and Phase 2 was never started.
    End point values
    AUTO2
    Number of subjects analysed
    11
    Units: Subjects
        Progressive disease
    0
        Partial response
    3
        Stable disease
    7
        Very good partial response
    1
    No statistical analyses for this end point

    Secondary: Proportion of Subjects for Whom an AUTO2 Product Can be Generated

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    End point title
    Proportion of Subjects for Whom an AUTO2 Product Can be Generated
    End point description
    Feasibility of product generation will be examined by assessing the number of AUTO2 successfully manufactured as a fraction of the number of subjects undergoing leukapheresis.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    AUTO2
    Number of subjects analysed
    12
    Units: Subjects
    12
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate

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    End point title
    Clinical Benefit Rate
    End point description
    Number of subjects exhibiting stringent complete response, complete response, very good partial response, partial response or minor response following treatment with AUTO2.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    AUTO2
    Number of subjects analysed
    11 [4]
    Units: Subjects
    4
    Notes
    [4] - 2 subjects were retreated; their best overall response is presented for this endpoint.
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    Duration of Response
    End point description
    Calculated from the date of first observation of sCR, CR, VGPR or PR to the date of disease progression, relapse or death, for subjects who were considered responders (achieved at least PR). Subjects who had not progressed, relapsed or died will be censored at the last adequate disease assessment.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    AUTO2
    Number of subjects analysed
    0 [5]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [5] - Analysis was not performed due to the study being terminated early and Phase 2 not being started.
    No statistical analyses for this end point

    Secondary: Time to Disease Progression

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    End point title
    Time to Disease Progression
    End point description
    Calculated from the date of AUTO2 treatment to the date of progression. Subjects who had not progressed, relapsed or died without progression/relapse will be censored at the last adequate disease assessment.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    AUTO2
    Number of subjects analysed
    0 [6]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [6] - Analysis was not performed due to the study being terminated early and Phase 2 not being started.
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    Progression Free Survival
    End point description
    Calculated from the date of AUTO2 treatment to the date of progression or death. Subjects who have not progressed or relapsed was censored at the last adequate disease assessment
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    AUTO2
    Number of subjects analysed
    0 [7]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [7] - Analysis was not performed due to the study being terminated early and Phase 2 not being started.
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    Descriptive analysis based on number of subjects alive at database lock (1-May-2020).
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    AUTO2
    Number of subjects analysed
    11
    Units: Subjects
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Expansion Followed by Persistence of RQR8/APRIL CAR Positive T Cells in the Peripheral Blood

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    End point title
    Number of Subjects with Expansion Followed by Persistence of RQR8/APRIL CAR Positive T Cells in the Peripheral Blood
    End point description
    Expansion and persistence of RQR8/APRIL CAR positive T cells as determined by quantitative polymerase chain reaction and/or flow cytometry.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    AUTO2
    Number of subjects analysed
    11
    Units: Subjects
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 until Day 60 post last AUTO2 infusion.
    Adverse event reporting additional description
    Adverse events are reported for the 11 subjects who received study treatment (safety analysis set).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    AUTO2
    Reporting group description
    Relapsed or refractory myeloma subjects. Results for adverse events are shown for the safety analysis set.

    Serious adverse events
    AUTO2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 11 (54.55%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metaplastic breast carcinoma
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    AUTO2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Hypotension
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Immune system disorders
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    General disorders and administration site conditions
    Catheter site bruise
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    4
    Fatigue
         subjects affected / exposed
    6 / 11 (54.55%)
         occurrences all number
    10
    Oedema peripheral
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    6 / 11 (54.55%)
         occurrences all number
    8
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Neutrophil count decreased
         subjects affected / exposed
    7 / 11 (63.64%)
         occurrences all number
    71
    Platelet count decreased
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    12
    Respiratory syncytial virus test positive
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Serum ferritin increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 11 (81.82%)
         occurrences all number
    31
    Febrile neutropenia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    29
    Thrombocytopenia
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    5
    Epistaxis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Oropharyngeal pain
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Tachypnoea
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    6
    Paraesthesia
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Tension headache
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    5 / 11 (45.45%)
         occurrences all number
    6
    Dry mouth
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Haematochezia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    3
    Stomatitis
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    6
    Back pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Bone pain
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    6
    Muscular weakness
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Dehydration
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Fluid overload
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Infections and infestations
    Enterovirus infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    External ear cellulitis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Metapneumovirus infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Parvovirus B19 infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Rhinovirus infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2017
    Protocol Version 2 - Summary of changes: - Administrative changes - Clarification of study design and eligibility criteria - Clarification for subjects who receive rituximab - Reduced biomarker sampling frequency - Safety Evaluation Committee monitoring introduced - Independent Data Monitoring Committee introduced
    07 Nov 2017
    Protocol Version 3 - Summary of changes: - Administrative changes - Updated study design - Updated patient numbers - Increased study duration - Modification of Schedule of Assessments - Update on Safety Management Guidelines - Clarifications in Eligibility section - Uniform descriptions added for product descriptions and pre-clinical information - Modifications to AE reporting period and conmeds
    19 Dec 2017
    Protocol Version 4 - Summary of changes: - Typographical and administrative changes - Updates to study design - Updates to overall patient number - Duration of study participation updated - DLT criteria updated - Update on general supportive care guidelines - Clarifications added for AE reporting - Updates to eligibility section - IMWG update 2016 for disease response evaluation - Statistical analysis modification
    30 Jan 2018
    Protocol Version 5 - Summary of changes: - Typographical changes - Updated summary of clinical studies - Dose-escalation details added - Schedule of assessments and sampling schedule updated - Updates to Inclusion/exclusion criteria - Re-treatment criteria clarification added - Discontinuation and re-enrolment into the study clarification added - Additional study visit and procedures added - Lifestyle restrictions added - Monitoring access clarified
    15 May 2018
    Protocol Version 6 - Summary of changes: - Typographical changes - DLT criteria modified - Re-treatment criteria modified - Inclusion/exclusion criteria amended - Guidelines for prevention, monitoring and management of adverse events amended - Pharmacologic Management of CRS aligned with packaging - Additional language added to Allowed Concomitant Medications/Therapies - Additional samples will be taken for Rituximab Rescue Therapy
    27 Jun 2018
    Protocol Version 7 - Summary of changes: - Typographical changes - Update on clinical experience so far - Decrease of Cohort 4 - Increase in DMSO quantity - Updated dosing information

    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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