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    Summary
    EudraCT Number:2006-004950-25
    Sponsor's Protocol Code Number:D-00272-CT2014001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-004950-25
    A.3Full title of the trial
    WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
    A.3.2Name or abbreviated title of the trial where available
    WT1 TCR transduced autologous T cells
    A.4.1Sponsor's protocol code numberD-00272-CT2014001
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT01621724
    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 SponsorCell Medica Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportCell Medica Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCell Medica Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1 Canal Side Studios, 8-14 St Pancras Way
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW1 0QG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442075544076
    B.5.5Fax number442071834745
    B.5.6E-mailalex.bloom@cellmedica.co.uk
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameWT1 TCR-transduced T cells
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 No
    D.3.11.3.2Gene therapy medical product Yes
    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 Information not present in EudraCT
    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
    Acute Myeloid Leukaemia and Chronic Myeloid Leukaemia in adults.
    E.1.1.1Medical condition in easily understood language
    Leukaemia
    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 10009013
    E.1.2Term Chronic myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PRIMARY OBJECTIVES
    1) To determine the feasibility of TCR gene transfer in a clinical setting.
    2) To identify organ toxicities or other side effects related to the re-infusion of TCR-Transduced T cells.
    3) Propose a safe dose of TCR-Transduced T cells for Phase II evaluation.
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES
    1) To determine the persistence and function of re-infused TCR-transduced T cells.
    2) To document disease responses where possible.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    GENERAL INCLUSION CRITERIA
    All patients will undergo detailed laboratory based assessment prior to the procedure (Appendix A3).
    a) Age ≥18 years and ≤75 years.
    b) Life expectancy ≥16 weeks (4 months).
    c) World Health Organisation (WHO) performance status of 0-2
    d) HLA A*0201 positive
    e) Completed previous course of chemotherapy ≥ 4 weeks prior to commencing the initial phase of the trial (leucapheresis for collection of patient PBMC).
    f) Peripheral blood total lymphocyte count >0.5x109/L.
    g) Informed consent in writing and ability to co-operate with treatment and follow up.
    h) Willing, able and available for collection of PBMC/ T cells by leucapheresis.
    i) Hepatitis B and C, HTLV-1, Syphilis and HIV negative.
    j) Free from serious concurrent illness.
    k) Female patients of child-bearing age must have a negative pregnancy test and agree to use reliable contraceptive methods for the duration of the therapy and for 6 months afterwards.
    l) Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards.
    m) Haematological and Biochemical Indices:
    - Haemoglobin (Hb) ≥ 7.0 g/dl; neutrophils ≥ 0.2 x 109/L; total lymphocytes >0.5 x 109/L; platelets (Plts) ≥ 40 x 109/L
    - serum bilirubin, Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 3 x upper normal limit
    - calculated creatinine clearance ≥ 30 ml/min (uncorrected value) or isotope clearance measurement ≥ 30ml/min

    DISEASE-SPECIFIC INCLUSION CRITERIA
    AML or CML proven by morphology, histology, immunophenotyping and cytogenetics (where available).

    ACUTE MYELOID LEUKAEMIA (AML):
    (1) Patients NOT eligible for BMT procedure with:
    (a) AML in 2nd CR or greater;
    (b) Good and Standard Risk* AML in 1st CR or PR in patients >60 years; and
    (c) Poor Risk* AML in 1st CR (slow remitters and/or adverse cytogenetics).
    (2) AML at 1st relapse post BMT in CR or PR after re-induction and consolidation.
    [NB, *risk category as defined by MRC criteria: Good Risk: t(15;17), t(8;21), inv 16; Poor Risk: -5; -7; del (5q); abn (3q) or complex (=/>4 abn)].

    CHRONIC MYELOID LEUKAEMIA (CML):
    1. Patients in chronic phase resistant to Glivec/Imatinib and 2nd generation tyrosine kinase inhibitors (eg., Dasatinib), AND NOT eligible for allogeneic BMT.
    2. Patients in chronic phase resistant to Glivec/Imatinib and with an identified mutation known to be resistant to 2nd generation tyrosine kinase inhibitors, AND NOT eligible for allogeneic BMT.
    3. Patients ≥ 50 years (and ineligible for myeloablative allo BMT), with a suboptimal response to Glivec/Imatinib and an identified mutation known to be resistant to 2nd generation tyrosine kinase inhibitors. These patients are at high risk of disease progression. Patients in this group would stop Glivec/Imatinib prior to leucapheresis and receiving TCR-transduced T cells. They will have monthly quantitative RT-PCR for Bcr-Abl and restart Glivec/Imatinib in the event of a log increase in transcript numbers.
    4. Patients in chronic phase, resistant to Glive/Imatininb and NOT eligible for allo BMT without access to 2nd generation tyrosine kinase inhibitors may be considered after discussion with the Chief Investigator.

    Resistance to Glivec is defined as (European Leukemianet Criteria, 2006):
    No Haematological Response (HR) at 3 months
    Incomplete HR or No Cytogenetic Response (CgR) at 6 months
    Less than partial CgR (Ph+ >35%) at 12 months
    Less than complete CgR at 18 months
    Loss of HR or CgR
    Development of highly resistant mutations
    Suboptimal response to Glivec is defined as (European Leukemianet Criteria, 2006):
    Less than complete Haematological response at 3 months
    Less than partial CgR (Ph+ >35%) at 6 months
    Less than complete CgR at 12 months
    Less than major MoR at 18 months
    Loss of major MoR
    Development of a mutation
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA
    a) Age <18 years or >75 years.
    b) Patients should not receive concurrent systemic corticosteroids whilst on the study.
    c) Within three months of having received fludarabine (at time of leucapheresis).
    d) Major thoracic and/or abdominal surgery in the preceding three to four weeks from which the patient has not yet recovered.
    e) Patients who are high medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.
    f) Patients with any other condition, which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
    g) Patients known to be serologically positive for Hepatitis B, C, HTLV-1, Syphilis or HIV.
    h) Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease
    i) Positive pregnancy test or reluctance to use contraception.
    j) Pregnant and lactating women are excluded.
    k) History of Severe Allergy.
    E.5 End points
    E.5.1Primary end point(s)
    PRIMARY ENDPOINTS AND OUTCOME MEASURES
    1) Document transduction efficiency and TCR expression on TCR-transduced T cells.
    2) Identify organ toxicities and other side effects.
    3) Perform integration site analysis on TCR-transduced T cells.
    E.5.2Secondary end point(s)
    •Document WT1-specific immune responses of TCR-transduced T cells
    pre and post infusion.
    •Detect persistence of TCR-transduced T cells by Vβ2.1 and tetramer staining and PCR for Vβ2.1 and TCR-vector fragments.
    •Identification of disease response.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 No
    E.8.1.1Randomised No
    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 No
    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 concerned2
    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 Information not present in EudraCT
    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
    Provided in the Trial Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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.1.3Elderly (>=65 years) Yes
    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 state18
    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)
    Patients will continue with standard palliative therapies. There will be no more infusion of gene-modified T cells to patients.
    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 Decision2008-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-17
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