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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-004380-31
    Sponsor's Protocol Code Number:CM-2013-01
    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:2015-01-12
    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 number2013-004380-31
    A.3Full title of the trial
    A Phase 2 open label study to investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive extranodal NK/T-cell lymphoma (ENKTCL).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate how well a product containing certain immune cells (EBV-specific T-cells) manufactured from the patient's own blood cells works in the treatment of patients with a rare type of non-Hodgkin's lymphoma (aggressive extranodal NK/T-cells lymphoma).
    A.3.2Name or abbreviated title of the trial where available
    CITADEL - Cellular Immunotherapy Treatment Antigen-directed for EBV Lymphoma
    A.4.1Sponsor's protocol code numberCM-2013-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01948180
    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 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 supportCancer Prevention and Research Institute of Texas
    B.4.2CountryUnited States
    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 pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address8-14 St Pancras Way
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW1 0QG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402075544070
    B.5.6E-mailinfo@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 nameCMD-003
    D.3.2Product code CMD-003
    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 INNAutologous EBV-specific T-cells
    D.3.9.2Current sponsor codeCMD-003
    D.3.9.3Other descriptive nameAUTOLOGOUS T-LYMPHOCYTES
    D.3.9.4EV Substance CodeSUB96123
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500000
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Aggressive EBV positive extranodal NK/T-cell lymphoma (ENKTCL)
    E.1.1.1Medical condition in easily understood language
    Aggressive EBV positive extranodal NK/T-cell lymphoma (ENKTCL) is a rare type of cancer that affects some types of blood cells. It is associated with Epstein Barr Virus (EBV).
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10034623
    E.1.2Term Peripheral T-cell lymphoma unspecified
    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 evaluate the overall response rate per independent endpoint assessment
    E.2.2Secondary objectives of the trial
    To assess the complete response rate (CR)
    To assess response duration
    To assess time to response
    To assess progression free survival (PFS)
    To assess disease free survival (DFS)
    To assess the overall survival (OS)
    To assess safety through the incidence of adverse events (AE)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    FOR SCREENING PHASE:
    1. Diagnosis of extranodal NK/T lymphoma, per WHO classification, which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
    2. a) Active Disease:
    (1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR
    2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR
    b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy (Appendix B)
    3. Male or female ≥ 18 years of age.
    4. Weigh ≥ 35 kg.
    5. ECOG performance score 0-2, inclusively (Appendix A).
    6. Negative β-hCG test in women of childbearing potential.
    7. Able to understand and comply with the requirements of the study and to provide written informed consent.
    8. Estimated life expectancy greater than four months.

    FOR TREATMENT PHASE:
    1. All Screening Phase inclusion criteria.
    2. Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
    3. Active disease based on any one of the following present at the baseline study visit or within two weeks prior to the baseline study visit:
    a. Imaging (may use local imaging)
    b. Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical signs.
    c. Detectable blood or plasma EBV DNA (may use local laboratory)
    4. Completed most recent course of chemotherapy at least 2 weeks prior to first study product dose.
    5. Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0. (Transfusion to achieve the hematological criteria is acceptable.)
    6. Pulse oximetry of ≥ 90% on room air.
    E.4Principal exclusion criteria
    FOR SCREENING PHASE:
    1. Known central nervous system (CNS) lymphoma.
    2. NK/T cell leukemia.
    3. Known hypersensitivity to the investigational product or any components in the final formulation (e.g. DMSO and/or HSA).
    4. Positive laboratory test for anti-HIV 1, 2; HBsAg, anti-HTLV-I; anti-HCV, or syphilis (Patients with anti-hepatitis B core antibody are eligible if negative for HBsAg).
    5. Use of systemic corticosteroids >0.5 mg/kg/day prednisolone or equivalent alternative corticosteroid within 10 days prior to obtaining 200 mL whole blood starting material.
    6. Patient is pregnant or lactating.
    7. Female patients of childbearing potential and male patients with partners of childbearing potential unwilling to use a highly effective method of birth control during the study and for 6 months after the study treatment is concluded.
    8. Clinically significant medical condition e.g. pulmonary, neurological, cardiovascular, metabolic, or hematologic that could jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.
    9. Active second malignancy, except for localized basal cell carcinoma of skin, squamous cell carcinoma of the skin or cervical carcinoma in situ.
    10. Previous non-hematological malignancy, except for adequately treated basal-cell carcinoma of skin, a squamous cell carcinoma of the skin or cervical carcinoma in situ without current evidence of disease, unless the tumor was treated with curative intent more than 5 years prior to study entry.
    11. Any prior allogeneic hematopoietic stem cell.
    12. Any prior solid organ transplant.
    13. Asparaginase-refractory disease, defined by any one of the following:
    a. Progression at any time during initial asparaginase-based chemotherapy and up to 3 months after end of initial asparaginase-based chemotherapy regimen; OR
    b. Failure to achieve at least PR with initial asparaginase-based chemotherapy, OR
    c. Persistence of significant (score 4 or 5) residual FDG-avid metabolic activity using the quantitative 5-point Deauville score following initial asparaginase based chemotherapy regimen.

    14. Absolute lymphocyte count (ALC) <400/µL.
    15. Any previous autologous EBV specific T cell treatment.
    16. History of any one of the following cardiovascular conditions within the past 3 months:
    a. Class III or IV heart failure as defined by the New York Heart Association.
    b. Cardiac angioplasty or stenting
    c. Documented myocardial infarction, or
    d. Unstable angina.
    17. Systemic fungal, bacterial, viral or other infection that is not controlled
    18. Third or greater relapse

    FOR TREATMENT PHASE:
    1. All Screening Phase exclusion criteria with following exception:
    a. ALC < 400/µL.
    2. Use of any investigational agents within prior 4 weeks.
    3. Radiotherapy within prior 3 weeks.
    4. Major surgery within prior 2 weeks.
    5. Signs/ symptoms of severe infection within prior 2 weeks.
    6. Systemic corticosteroids within 24 hours prior to study product administration.
    7. Evidence of hepatic dysfunction based on serum total bilirubin > 3 times upper limit of normal (ULN), or ALT > 5 times ULN or AST > 5 times ULN.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate, defined as best observed response (CR or PR) (Group A only)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumour response will be measured at day 60, day 180, day 270 and day 365.
    E.5.2Secondary end point(s)
    Complete response rate (CR) (Group A only)
    Response duration (Group A only)
    Time to response (Group A only)
    Progression free survival (PFS) (Group A only)
    Disease free survival (DFS)
    Overall Survival (OS)
    Adverse Events (AEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of study (up to 2 years after last dose).
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Korea, Republic of
    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 subject long-term survival appointment. The final study visit occurs at the 12 month timepoint. Study participants will be followed for a further 18 months through telephone and/ or medical records such that end of study will occur when the last follow-up appointment for the last subject has been completed.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 35
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 35
    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 National Institute for Health Research Cancer Research Network (NCRN)
    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 Decision2015-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-05
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