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    Summary
    EudraCT Number:2020-000722-26
    Sponsor's Protocol Code Number:AVM-003-HC
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-000722-26
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study conducted to determine if ALVR105 is safe and a good treatment for hemorrhagic cystitis (HC) caused by a viral infection after allogeneic hematopoietic cell transplant (HCT).
    A.4.1Sponsor's protocol code numberAVM-003-HC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04390113
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlloVir, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlloVir, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlloVir, Inc.
    B.5.2Functional name of contact pointClinical Trials Information Line
    B.5.3 Address:
    B.5.3.1Street AddressKirby Grove, 2925 Richmond Ave, Suite 1200
    B.5.3.2Town/ cityHouston, Texas
    B.5.3.3Post code77098
    B.5.3.4CountryUnited States
    B.5.6E-mailClinicalTrials@allovir.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2260
    D.3 Description of the IMP
    D.3.1Product nameViralym-M
    D.3.2Product code ALVR105
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNViralym-M (ALVR105)
    D.3.9.2Current sponsor codeViralym-M (ALVR105)
    D.3.9.3Other descriptive nameAllogeneic multi-virus specific T lymphocytes targeting BK Virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus and adenovirus
    D.3.9.4EV Substance CodeSUB197084
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 × 10^7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboDispersion for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant.
    E.1.1.1Medical condition in easily understood language
    Inflammation of the bladder caused by viral infection following bone marrow transplant.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10059348
    E.1.2Term Viral hemorrhagic cystitis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the time to resolution of macroscopic hematuria in recipients of Viralym-M (also known as ALVR105) to that in patients receiving placebo.
    E.2.2Secondary objectives of the trial
    1) To compare the time to resolution of bladder pain as measured by Clinical Outcome Assessments (COAs) in recipients of Viralym-M to that in patients receiving placebo.
    2) To assess number of days in the hospital.
    3) To assess the incidence and severity of acute graft versus host disease (GVHD) and cytokine release syndrome (CRS)
    4) To assess time to resolution of viremia for all target viruses.
    5) To assess average daily bladder pain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria in order to be eligible to participate in the study:
    1. Over 1 year of age at the time of informed consent/assent.
    2. Had an allogeneic hematopoietic cell transplant (HCT) performed at least 21 days and not more than 1 year prior to randomization.
    3. Myeloid engraftment confirmed.
    4. Diagnosed with Hemorrhagic Cystitis.
    5. At least 1 identified, suitably matched Viralym-M cell line for infusion is available.
    6. Willing and able to provide written informed consent to participate in the study, or a parent or legal guardian is willing and able to provide written informed consent and the potential pediatric patient is able to provide assent in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations.
    7. Agree to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment for all patients of childbearing potential.
    8. A negative serum pregnancy test for female patients of childbearing potential
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from participation in the study:
    1. Ongoing therapy with high-dose systemic corticosteroids.
    2. Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies within 28 days of randomization.
    3. Evidence of active Grade >2 acute GVHD.
    4. Presence of uncontrolled or progressive bacterial or fungal infections.
    5. Presence of progressive, uncontrolled viral infections not targeted by Viralym-M.
    6. Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
    7. Known or presumed pneumonia secondary to any organism.
    8. Donor lymphocyte infusion performed within 21 days prior to randomization.
    9. Hemodynamic or respiratory instability.
    10. Hemoglobin <7 g/dL despite RBC transfusions.
    11. Evidence of active hepatic sinusoidal obstruction syndrome.
    12. Liver dysfunction.
    13. Renal dysfunction.
    14. Evidence of encephalopathy.
    15. Relapse of primary malignancy.
    16. Receipt of other investigational antiviral treatments (eg, brincidofovir) within 28 days prior to randomization and throughout the duration of the study.
    17. Pregnant or lactating or planning to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to resolution of macroscopic hematuria in patients with documented BK viruria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until the patient reaches the primary endpoint, the assessments will be performed daily up to Week 12. After Week 12, the assessments will be performed twice per week until Week 24.
    E.5.2Secondary end point(s)
    1) Time to resolution of bladder pain as measured by age-appropriate COAs.
    2) Number of days in the hospital.
    3) Time to resolution of viremia for all target viruses.
    4) Average daily bladder pain.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the 1st secondary end point – the assessments will be performed daily up to Week 12. After Week 12, the assessments will be performed weekly until Week 24.
    For 2nd and 3rd secondary end points - Week 24.
    For 4th secondary end point - Week 6.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit last subject (LVLS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 35
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 11
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 125
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation IMPACT Partnership
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-22
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