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    Summary
    EudraCT Number:2016-004043-36
    Sponsor's Protocol Code Number:004:TCELL
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-26
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-004043-36
    A.3Full title of the trial
    CD19-TARGETING 3RD GENERATION CAR T CELLS FOR REFRACTORY B CELL MALIGNANCY – A PHASE II TRIAL
    Behandling av terapiresistent B cells malignitet med CD19-specifika CAR T celler - en fas II studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    T cell therapy for patients with leukemia or lymphoma
    T cellsterapi för behandling av leukemi och lymfom.
    A.3.2Name or abbreviated title of the trial where available
    004:TCELL
    A.4.1Sponsor's protocol code number004:TCELL
    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 SponsorUppsala University
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAFA Insurance AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUppsala University
    B.5.2Functional name of contact pointTrial Manager
    B.5.3 Address:
    B.5.3.1Street AddressRudbeck Laboratory C11, 2tr. Dag Hammarskjoldsv 20
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code SE-751 85
    B.5.3.4CountrySweden
    B.5.4Telephone number460702321978
    B.5.6E-mailtanja.lovgren@igp.uu.se
    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 name3rd generation anti-CD19 CAR T cells
    D.3.2Product code 3rdCARTa19
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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) Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberAutologous engineered anti-CD19 Chimeric Antigen Receptor (CAR+) T-cells, EMA/204251/2016
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    CD19+ B cell lymphoma or leukemia
    CD19+ B cells-malignitet
    E.1.1.1Medical condition in easily understood language
    Leukemia and lymphoma, blood cell cancer
    Leukemi och lymfom, blodcancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the feasibility and safety of two administrations of CAR T cells to patients with disseminated B cell lymphoma or leukemia.
    - To evaluate long-term toxicity of CAR T cells by an extended follow-up period (12-24 months) when patients are analyzed even if they have progressed in their disease and/or received another therapy.
    - To evaluate whether two courses of gemcitabine given in association with CAR T cells can increase the effect of CAR T cell therapy.
    E.2.2Secondary objectives of the trial
    - Establish persistence and function of CAR T cells.
    - To evaluate if FDG-PET MRI is a suitable technique to determine therapy response
    - Evaluate the level of B cells as a measurement of CAR T cell efficacy.
    - Evaluate immune profile shifts post treatment as a measurement of CAR T cell function.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Relapsed or refractory CD19+ B-cell lymphoma, leukemia or Hodgkin lymphoma with no other curative treatment option available.
    2. Measurable disease
    3. All ages
    4. Performance status ECOG 0-2 (Appendix IV)
    5. Fertile females/male must consent to use highly effective* contraceptives during the participation of the trial
    6. Signed informed consent
    * This study follows the 2014 CTFG guidance document “Recommendations related to contraception and pregnancy testing in clinical trials” (Appendix XII). The patients must consent to use highly effective contraceptives during the participation of the trial. Contraceptive methods considered highly effective by the guidance document are those with a Pearl index <1% when used consistently and correctly. Highly effective contraceptives include combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation via e.g. oral, transdermal or intravaginal administration. Also included are progesterone-only hormonal contraception associated with inhibition of ovulation via e.g. oral, injectable or implantable administration. Other acceptable methods include intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner and sexual abstinence. Methods not included are e.g. condoms, diaphragm with spermicide and low-dose progesterone.
    E.4Principal exclusion criteria
    1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures
    2. Patients with primary CNS lymphoma
    3. Known human immunodeficiency virus (HIV) infection
    4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection)
    5. Other serious underlying medical conditions, which, in the Investigator’s judgment, could impair the ability of the patient to perform the treatment
    6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half-lives of that drug, which is longest
    7. Pregnancy
    8. Patients that do not consent to that tissue and blood samples are stored in a biobank
    9. Patients whose cells cannot be manufactured
    E.5 End points
    E.5.1Primary end point(s)
    - Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events.
    - Tumor response measured as best response and over all response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
    E.5.2Secondary end point(s)
    - Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies.
    - Determination of activation markers on CAR T cells such as CD107a.
    - Determination of tumor size and the tumor marker CD19.
    - Determination of the levels of circulating B cells.
    - Determination of the presence of immunological markers in blood and biopsies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 Yes
    F.1.1Number of subjects for this age range: 25
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 1
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 13
    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 state25
    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)
    Care within the normal healthcare according to the standard guidelines for the respective malignanices. Information about the patient receiving CAR T cells will be found in the patient medical charts together with contact information to the principal investigator. If the patient would benefit from further treatment with investigational drug the Principal Investigator will discuss the possibility to apply for an amendment to protocol with the Sponsor Representative.
    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 Decision2017-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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