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    Summary
    EudraCT Number:2018-000813-19
    Sponsor's Protocol Code Number:EURE-CART-1
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-02-27
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2018-000813-19
    A.3Full title of the trial
    A Phase I-IIa trial to assess the safety and antitumor activity of autologous CD44v6 CAR T-cells in acute myeloid leukemia and multiple myeloma expressing CD44v6.
    Klinická studie fáze I-IIa k posouzení bezpečnosti a protinádorové aktivity autologních CAR (CD44v6) T lymfocytů u pacientů s akutní myeloidní leukémií a mnohočetným myelomem s expresí CD44v6.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and antitumor activity of autologous CD44v6 CAR T-cells in acute myeloid leukemia and multiple myeloma expressing CD44v6.
    A.4.1Sponsor's protocol code numberEURE-CART-1
    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 SponsorMolMed S.p.A.
    B.1.3.4CountryItaly
    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 supportMolMed S.p.A.
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportEuropean Committee: Grant agreement number 733297-EURE-CART-H2020
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMolMed S.p.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressVia Meucci, 3
    B.5.3.2Town/ cityBresso (MI)
    B.5.3.3Post code20091
    B.5.3.4CountryItaly
    B.5.4Telephone number00390221277234
    B.5.5Fax number00390221277239
    B.5.6E-maileurecart1.team@molmed.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMLM-CAR44.1 T-cells
    D.3.2Product code MLM-CAR44.1 T-cells
    D.3.4Pharmaceutical form 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 INNMLM-CAR44.1 T-cells
    D.3.9.2Current sponsor codeMLM-CAR44.1 T-cells
    D.3.9.3Other descriptive nameVIABLE T-CELLS
    D.3.9.4EV Substance CodeSUB186020
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000000 to 10000000
    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 No
    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
    Acute myeloid leukemia and Multiple myeloma
    E.1.1.1Medical condition in easily understood language
    Acute myeloid leukemia and multiple myeloma
    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 LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I:
    1. To determine the maximum tolerated dose (MTD) and recommended phase IIa dose of MLM-CAR44.1 T-cells in patients with relapsed/refractory acute myeloid leukemia (AML) or multiple myeloma (MM) expressing CD44v6.
    2. To evaluate the overall safety of treatment with MLM-CAR44.1 T-cells.

    Phase IIa:
    To evaluate hematological response to MLM-CAR44.1 T-cells in AML and MM.
    E.2.2Secondary objectives of the trial
    Phase I:
    1. To evaluate hematological response to MLM-CAR44.1 T-cells in AML and MM.
    2. To characterize the in vivo pharmacokinetic profile (engraftment, persistence, trafficking) of MLM-CAR44.1 T-cells.
    3. To assess suicide gene activation and elimination of transduced cells through administration of ganciclovir in case of cytokine release syndrome (CRS) or other MLM-CAR44.1 T-cell related toxicities.
    4. To conduct an ancillary study, including but not limited to the characterization of the cellular composition of circulating LNGFR+ (CAR T-cells) and LNGFR- cells, and the monitoring of the patient’s immune status through analyses of peripheral blood mononuclear cells (PBMC).
    5. To set-up a validation process among the participating centers for the CD44v6 marking of tumor cells (AML and MM).

    Phase IIa:
    1. To evaluate the antitumor activity of MLM-CAR44.1 T-cells.
    For more objectives please refer to the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent before any study-related procedure.
    2. Adults and children:
    a) Adults 18 to 75 years old with AML or MM
    b) Children 1 to 17 years old with AML, only in Phase IIa
    3. Confirmed diagnosis of AML or MM as follows:
    a) AML: Primary or secondary AML (any subtype except acute promyelocytic leukemia) according to World Health Organization (WHO) classification
    b) MM with measurable disease as defined by the International Myeloma Working Group (IMWG).
    4. Patients with relapse or refractory disease:
    a) AML patients must be unlikely to benefit from cytotoxic chemotherapy as follows:
    • Leukemia refractory to at least 2 induction attempts (use of a hypomethylating agent for at least 4 cycles can be considered a line of treatment).
    • Leukemia in relapse within 1 year following complete response (CR) after at least 2 induction attempts (use of a hypomethylating agent for at least 4 cycles can be considered a first line of treatment).
    • High-risk leukemia in adults according to 2017 European LeukemiaNet (ELN) in first relapse after a hypomethylating agent or a cycle containing cytarabine at a dose ≥ 1g/sqm a day (e.g. FLAG-IDA), except for FLT3-mutated AML.
    • High-risk leukemia in children as defined by the Italian Association of Pediatric Hematology and Oncology (AIEOP).
    b) Patients with MM must have a relapse or refractory disease after at least 4 different prior treatments in 3 treatment lines, or 4 treatments in 2 treatment lines in case of early relapsing patients (relapse in less than 1.5 years). Treatments include:
    • Proteasome inhibitor
    • High-dose alkylating agent if patient less than 70 years old
    • Immunomodulatory drug (IMID)
    • A monoclonal antibody (i.e. anti CD38 monoclonal antibody)


    5. Positive CD44v6 expression on tumor cells by flow cytometry.
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    7. Life expectancy of at least 12 weeks.
    8. Adequate organ function:
    a) Alanine aminotransferase (ALT) level within 2.5 times the institutional upper limit of normal (ULN).
    b) aspartate aminotransferase (AST) level ≤ 2.5 x ULN.
    c) Total bilirubin level ≤ 1.5 x ULN, or ≤ 2.5 x ULN in case of history of Gilbert’s disease.

    d) Serum creatinine ≤ 2.0 mg/dL or a calculated or measured creatinine clearance ≥ 45mL/min.
    e) Corrected Diffusing Capacity of Carbon Monoxide (DLCO) (via Dinakara Equation) or FEV1 of  66% without dyspnea on slight activity after hemoglobin correction.
    f) Left ventricular ejection fraction ˃ 45%.
    9. Recovery from toxicities of clinical consequence attributed to previous chemotherapy to CTCAE v5.0 Grade 1 (i.e., certain toxicities such as alopecia will not be considered in this category).
    10. Ability to comply with study procedures, including hospitalization and protocol-specified acquisition of blood and/or bone marrow specimens.

    11. Willing to be followed up long-term (15 years) as required by health authorities for cell and gene therapy products
    12. Women of childbearing potential must have test negative for pregnancy at enrolment and during the study and agree to use an effective method of contraception.
    E.4Principal exclusion criteria
    1. History of or candidate for allogeneic stem cell transplantation.

    2. Cardiovascular, pulmonary, renal, and hepatic 
functions that in the judgment of the investigator are insufficient to undergo investigational CAR T-cell therapy.
    3. Any history of or suspected current autoimmune disorders (apart from vitiligo, resolved childhood atopic dermatitis, Graves’ disease clinically controlled).
    4. History of rheumatologic disorders requiring specific treatment at any time in the patient’s medical history.
    5. Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed. 


    6. Known or suspected central nervous system (CNS) leukemia. 

    7. Presence or history of myeloid sarcoma or any extramedullary mass.
    8. Any medical or psychiatric condition that may limit compliance or increase safety risks, such as:
    a) Active uncontrolled infection (including, but not limited to viral, bacterial, fungal, or mycobacterial infection).

    b) Patients with known multiple antibiotic resistant infections in their clinical history.
    c) Known human immunodeficiency virus infection, active or chronic hepatitis B or C infection. 

    d) Grade 3 or 4 bleeding. 


    e) Uncontrolled hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 100 mm Hg). 

    f) Clinically significant arrhythmia, clinically significant baseline QTcF, or QTcF > 480 msec. 

    g) Unstable angina. 

    h) Myocardial infarction within 6 months prior to study drug administration. 

    i) Clinically significant heart disease (e.g. CHF NYHA III or IV, unstable coronary artery disease, myocardial infarction < 6 mo. prior to study entry).
    j) Pregnancy or breast feeding.
    k) Major surgery or trauma within 4 weeks before enrollment. 

    l) Dementia or altered mental status that would preclude sufficient understanding to provide informed consent.
    Once all the above eligibility criteria are confirmed, a lymphocyte apheresis product of non-mobilized cells must be received and accepted by the manufacturing site. Note: the lymphocyte apheresis product will not be shipped or assessed for acceptance by the manufacturing site until documented confirmation of all other inclusion/exclusion criteria have been satisfied.

    Prior to lymphocyte apheresis (week -9 to -7), the following criteria must be met:
    1. Peripheral blast count ≤ 20,000/mm3 (AML).
    2. No treatment with any other investigational agent in the previous 4 weeks.
    3. No treatment with an immunostimulatory agent (IMIDs are allowed) or any cell therapy in the previous 30 days.
    4. Negative to the following tests: HCV (Antibody, NAT), HIV 1-2 (p24, AB, Ag and NAT), total Ig Treponema Pallidum (if positive perform specific test), Australia HBsAg, total anti HB core Ab (if positive perform HBV DNA NAT), mycoplasma (PCR or IgM) and HTLV I-II.

    Prior to lymphodepleting chemotherapy and MLM-CAR44.1 T-cell infusion (day -5 to day -3), the following criteria must be met:
    1. Evidence of active disease at the beginning of lympho-depleting chemotherapy.
    2. The following medications are excluded and should not be administered concomitantly or following lymphodepleting chemotherapy:
    a) Monoclonal antibodies in the 8 weeks prior to MLM-CAR44.1 T-cell infusion are prohibited.
    b) Salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide, proteasome inhibitors, IMIDs) must be stopped > 2 weeks prior to lymphodepleting chemotherapy
    c) Granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to study CAR T-cell administration.
    d) Immunosuppressant medications in the 2 weeks prior to CAR T-cell administration.
    e) Cytosine arabinoside < 100 mg/m2/day must be stopped > 1 week prior to MLM-CAR44.1 T-cell infusion.
    f) Therapeutic systemic doses of steroids must be stopped > 72 hours prior to product infusion. However, < 12 mg/m2/day hydrocortisone or equivalent are allowed as physiological replacement doses of steroids.
    g) Hydroxyurea must be stopped > 72 hours prior to MLM-CAR44.1 T-cell infusion.
    3. No cardiovascular, pulmonary, renal, and hepatic 
functions that in the judgment of the investigator are insufficient to undergo investigational CAR T-cell therapy.
    4. Female patients of childbearing potential must have a negative pregnancy test within 24 hours prior to starting lymphodepleting therapy
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    1. MTD established through BOIN design and the following DLTs:
    a. Grade 4 CRS
    b. Grade 3 or higher CRS not responsive to therapy with steroids and or tocilizumab/siltuximab within 24 hours
    c. Grade 3 or higher toxicity possibly related to treatment with MLM-CAR44.1 T-cells excluding hematological toxicities
    d. Skin toxicities:
    - NCI-CTC grade 3 or higher erythroderma (generalized exfoliative dermatitis)
    - Stevens-Johnson syndrome
    - Any other grade 3 or higher skin toxicity histologically confirmed as being related to CAR T-cell treatment
    e. Grade 3 or higher neurotoxicity
    2. Type, frequency and severity of adverse events and monitoring of systemic reactions (fever, tachycardia, nausea and vomiting, joint pain, skin rash).
    3. Absence of replication competent retrovirus (RCR) monitored by DNA PCR for the Galv gene.

    Phase IIa:
    Hematologic disease response:
    - AML: CR, CRi and PR rate as per ELN criteria.
    - MM: ORR: (sCR, CR, VGPR, and PR) as per IMWG criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I:
    1. Within 30 days following CAR T-cell infusion
    2. For 30 days following CAR T-cell infusion
    3. 3, 6, 12 months after infusion and then yearly

    Phase IIa:
    - 2 months after MLM-CAR44.1 T-cell infusion
    - 3 months after T-cell infusion
    E.5.2Secondary end point(s)
    Phase I:
    1. Hematologic disease response:
    a. AML: complete response (CR), incomplete response (CRi) and partial response (PR) according to ELN criteria.
    b. MM: overall response rate (ORR): stringent complete response (sCR), CR, very good partial response (VGPR) and partial response (PR) according to IMWG criteria.
    2. Levels of circulating MLM-CAR44.1 T-cells by flow cytometry.
    3. Suicide gene activation and elimination of transduced cells through administration of ganciclovir in case of cytokine release syndrome or other significant MLM-CAR44.1 T-cell related toxicities.
    4. To set-up a validation process among the participating centers for the CD44v6 marking of tumor cells (AML and MM).

    Phase IIa:
    1. Hematologic disease response:
    a. AML: CR, CRi and PR rate as per ELN criteria, 1 month and 6 months after MLM-CAR44.1 T-cell infusion. Morphologic leukemia-free state (MLFS).
    b. MM: ORR (sCR, VGPR and PR) as per IMWG criteria.
    2. Overall Survival (OS) at 2 years.
    3. Disease-Free Survival (DFR) in AML patients.
    4. Event Free Survival (EFS) in AML patients.
    5. Progression Free Survival (PFS) in MM patients at 2 years.
    6. Duration of Remission (DOR) in MM patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I:
    1a. 1 and 2 months following MLM-CAR44.1 T-cell infusion
    1b. 1 and 3 months following T-cell infusion
    2. At day 7, 14, 21, 28, 60, 90, 180
    3. For each dose level
    4. During the study

    Phase IIa:
    1a. 1, 2 and 6 months after MLM-CAR44.1 T-cell infusion
    1b. 1,2 and 6 months after T-cell infusion
    2. From MLM-CAR44.1 T-cell infusion to death due to any cause
    3. From achievement of response to relapse or death due to any cause during response
    4. From the date of MLM-CAR44.1 T-cell infusion to the date of the earliest of the following: last follow-up, resistance, relapse or death due to any cause
    5. From MLM-CAR44.1 T-cell infusion to progression/relapse or death due to any cause
    6. From achievement of response to relapse or death due to any cause
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Antitumor activity of autologous CD44v6 CAR T-cells
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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) No
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years4
    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 Yes
    F.1.1Number of subjects for this age range: 7
    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: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 68
    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 to be followed for 15 years after MLM-CAR44.1 T-cell infusion as per health authority guidelines.
    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 Decision2019-09-04
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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