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    Summary
    EudraCT Number:2015-004058-17
    Sponsor's Protocol Code Number:CV-006
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-12-09
    Trial results View 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 ConcernedSweden - MPA
    A.2EudraCT number2015-004058-17
    A.3Full title of the trial
    An open-label, randomised, Phase II study to investigate the efficacy and
    safety of ALECSAT treatment as an add-on therapy to radiotherapy and
    temozolomide in patients with newly diagnosed glioblastoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, randomised, Phase II study to investigate the efficacy and
    safety of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells
    (ALECSAT) treatment as an add-on therapy to radiotherapy and
    temozolomide (standard of care) in patients with newly diagnosed
    glioblastoma (malignant primary brain tumor)
    A.4.1Sponsor's protocol code numberCV-006
    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 SponsorCytoVac A/S
    B.1.3.4CountryDenmark
    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 supportCytoVac A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytoVac A/S
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressVenlighedsvej 6
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code29
    B.5.3.4CountryDenmark
    B.5.4Telephone number+00454557 2245
    B.5.6E-mailkaw@cytovac.dk
    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/3/13/1197
    D.3 Description of the IMP
    D.3.1Product nameALECSAT
    D.3.4Pharmaceutical form Suspension for injection
    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 INNNo INN has been allocated to ALECSAT
    D.3.9.3Other descriptive nameAUTOLOGOUS T-LYMPHOCYTES
    D.3.9.4EV Substance CodeSUB96123
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000000 to 1000000000
    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) Yes
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glioblastoma multiforme
    E.1.1.1Medical condition in easily understood language
    Advanced brain cancer Glioblastoma multiforme
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To obtain preliminary but not conclusive evidence by analysing PFS in patients receiving ALECSAT as add-on therapy to radiotherapy and TMZ (SOC) versus patients receiving SOC only.
    E.2.2Secondary objectives of the trial
    a) To compare OS between patients who received ALECSAT as an add-
    on therapy to SOC versus patients who received SOC only.
    b) To compare OS rate at 12 and 24 months between patients who
    received ALECSAT as an add-on therapy to SOC versus patients who
    received SOC only.
    c) To assess the safety of ALECSAT treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients, aged between 18 and 70.
    2. Histologically confirmed, newly diagnosed glioblastoma, including
    gliosarcoma.
    3. Eligible for combined radiotherapy and TMZ treatment. (Stupp
    treatment)
    4. Patients with complete or partial tumour resection. For patients
    with limited tumour volume, biopsy is acceptable.
    5. WHO Performance status 0-2.
    6. Body weight 40 ≥ kg (males), 50 ≥ kg (females).
    7. Able and willing to provide written informed consent and comply
    with the study protocol and procedures.
    8. Women of child-bearing potential must have a negative pregnancy
    test at screening and agree to use acceptable methods of
    contraception during the study. A highly effective method of birth
    control is defined as those which result in a low failure rate (i.e.
    less than 1% per year) when used consistently and correctly such
    as implants, injectables, combined oral, intravaginal and
    transdermal contraceptives, some intrauterine devices (IUDs),
    intrauterine system (IUS), bilateral tubal occlusion, sexual
    abstinence or vasectomised partner. True abstinence should be
    consistent with the preferred and usual lifestyle of the patient.
    Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-
    ovulation methods) and withdrawal are not acceptable methods of
    contraception.
    E.4Principal exclusion criteria
    1. Prior treatment for brain tumours at study entry.
    2. Prior treatment with temozolomide at study entry.
    3. Females who are pregnant, planning to become pregnant or
    breastfeeding.
    4. Positive tests for anti- human immunodeficiency virus (HIV)-1/2;
    HBsAg, anti HBc, anti-HCV or being positive in a Treponema
    Pallidum test (syphilis).
    5. Patients who may have been exposed to high risk contagious virus
    within a reasonable time prior to enrolment should be excluded,
    unless the patient has been tested negative. e.g. by travelling in
    areas of the world with known high risk of infection or known
    epidemics, (in particular but not limited to West Nile virus (in
    season), Dengue fever, Zika or Ebola when outbreaks are
    recognized)
    6. Patients from high incidence areas for Human T-Lymphotropic
    Virus (HTLV-1) virus or who has a parent or spouse from a high
    incidence area must be excluded unless tested negative for HTLV-1
    virus.
    7. Known allergy to study medication.
    8. Any condition or illness that, in the opinion of the Investigator,
    would compromise patient safety or interfere with the evaluation
    of the safety of the investigational drug.
    9. Any concurrent illness that may worsen or cause complications in
    connection with blood donation, for example uncontrolled
    epilepsy, cardiovascular, cerebrovascular or respiratory disease.
    10. Use of immunosuppressant drugs with the exception of steroids.
    11. Blood transfusion within 48 hours prior to the donation of blood
    for ALECSAT production.
    12. Low haemoglobin count, in the opinion of the Investigator.
    13. Lymphocyte count <0.3 x 10E9 /litre.
    14. Receiving any other experimental treatment, including
    compassionate use programs and other interventional clinical
    studies for glioblastoma, within 30 days prior to inclusion, at the
    moment of inclusion or during active treatment within the
    assigned group.
    15. TMZ contraindication.
    E.5 End points
    E.5.1Primary end point(s)
    PFS is measured as the time from surgical resection to the date of investigator assessed progressive disease (PD) or death by any cause. PD will be declared based on MRI scans, clinical status, and corticosteroid usage according to the Revised Assessment for Neuro-Oncology (RANO) criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis will be carried out when 47 events (investigator assessed progression or death by any cause) have been observed. Twenty-four months after recruitment to the study has closed, treatment and data collection for any patients still alive will end and the study will close. Any data collected for patients still alive after the point of final analysis (47 events) until study closure (24 months after recruitment has closed) will be analysed and included as an addendum to the final report.
    E.5.2Secondary end point(s)
    Efficacy
    a) OS time is measured from time of surgical resection until death
    for any reason.
    b) Proportion of patients alive at 12 and 24 months after
    randomization (1-year and 2-year OS).

    Safety Endpoints:
    • Adverse events and pregnancies
    • Safety laboratory parameters
    • Immune system status

    Exploratory Endpoint:
    • PFS measured as the time from surgical resection to the date of
    PD centrally assessed
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy
    a) OS time is measured from time of surgical resection until death
    for any reason.
    b) Proportion of patients alive at 12 and 24 months after
    randomization (1-year and 2-year OS).

    Safety Endpoints:
    • Adverse events and pregnancies
    • Safety laboratory parameters
    • Immune system status

    Exploratory Endpoint:
    • PFS measured as the time from surgical resection to the date of
    PD centrally assessed
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Radiotherapy & temozolomide (standard of care) only, followed by second line treatment if necessary
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    24 months after recruiment has closed
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    All surviving patients will continue to receive normal standard of care
    after the study.

    As with previous studies involving the ALECSAT treatment there may be
    a possibility that patients randomised to the investigational treatment
    will be offered continued treatment on a "Named Patient" basis.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-02-24
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