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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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:2022-000557-88
    Sponsor's Protocol Code Number:Anti-CD19-ALL
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-30
    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 ConcernedGermany - PEI
    A.2EudraCT number2022-000557-88
    A.3Full title of the trial
    A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab (MOR00208) in Pediatric Patients with Relapsed or Refractory Acute B Lineage Leukemia
    Durchführung einer multizentrischen, prospektiven Phase I/II Studie zur Überprüfung der Sicherheit und der Wirksamkeit von Tafasitamab (MOR00208) bei pädiatrischen Patienten mit Rückfall einer akuten B-Zell Leukämie bzw. Behandlungs-refraktärer akuter B-Zell Leukämie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tafasitamab against childhood leukemia
    Tafasitamab gegen Leukämie im Kindesalter
    A.3.2Name or abbreviated title of the trial where available
    Anti-CD19-ALL
    A.4.1Sponsor's protocol code numberAnti-CD19-ALL
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05366218
    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 SponsorUniversity Hospital Tuebingen
    B.1.3.4CountryGermany
    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 supportIncyte Biosciences International Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Pediatric Clinical Studies
    B.5.2Functional name of contact pointCPCS
    B.5.3 Address:
    B.5.3.1Street AddressFrondsbergstr. 23
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72070
    B.5.3.4CountryGermany
    B.5.4Telephone number004970712981469
    B.5.5Fax number00497071294857
    B.5.6E-mailcd19-studie@med.uni-tuebingen.de
    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 Yes
    D.2.1.1.1Trade name Tafasitamab
    D.2.1.1.2Name of the Marketing Authorisation holderIncyte Biosciences
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTafasitamab
    D.3.2Product code MOR00208
    D.3.4Pharmaceutical form Powder for concentrate for 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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 Yes
    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
    B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL) refractory to standard treatment or with relapsed disease
    E.1.1.1Medical condition in easily understood language
    Leukemia in childhood
    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 10024338
    E.1.2Term Leukemia lymphoblastic acute
    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
    Part I: To determine the recommended dose of MOR00208 in pediatric patients on the basis of the maximum tolerated dose (MTD).
    Part II: To evaluate the time until hematological relapse (> 5% leukemic blasts) or increase of MRD ≥ 2 log in bone marrow during an observation time of 545 days accounting for competing risks.
    E.2.2Secondary objectives of the trial
    Part I:
    1. To evaluate the pharmacokinetics with measurement of plasma concentrations of MOR00208
    2. Assessment of Safety of MOR00208 by NCI Common Toxicity Criteria, version 5.0.
    Part II:
    1. To determine the rate of patients with "Success of treatment", defined as survival without newly emerging MRD or increasing MRD ≥ 2 log in bone marrow or peripheral blood or unacceptable toxicity/infections.
    2. To evaluate the overall survival.
    3. To evaluate changes in minimal residual disease during and after treatment in bone marrow aspirates with evaluation of the rate of patients with MRD reduction of at least 1 log at any time point compared to baseline.
    4. To evaluate changes in peripheral B cell numbers by flow cytometry in peripheral blood until the end of follow-up.
    5. To evaluate the cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts.
    6. Assessment of Safety of MOR00208 by NCI Common Toxicity Criteria, version 5.0.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age < 18 years at enrollment
    o only children ≥ 3 years at enrollment will be enrolled prior to the identification of the recommended Phase II dose (maximum tolerated dose, MTD)
    • B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)
    • Patients must have either underwent a first allogeneic stem cell transplantation with newly emerging or persistent MRD load posttransplant or have received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT or underwent a second or subsequent allogeneic stem cell transplantation irrespective of MRD after SCT
    • Informed consent must be given by patients or legal representatives
    E.4Principal exclusion criteria
    • Frank relapse (>5% leukemic blasts)
    • Philadelphia chromosome-positive (Ph+) ALL
    • Ejection fraction <25% on echocardiography
    • Cystatin C-clearance <40ml/min
    • Liver function abnormalities with bilirubin >4 mg/dL and elevation of transaminases higher than 400 U/L
    • Severe infection (HIV, Chronic active viral hepatitis), tests have to be conducted at screening
    • Acute GvHD III-IV or extensive chronic GvHD
    • The following immunosuppressive drugs (≥ 1 week of administration): steroids ≥ 1mg/kg body weight, cytostatics (except intrathecal/intracerebroventricular application for CNS treatment)
    • Application of other experimental therapy modalities in the last 4 weeks
    • Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukencephalopathy
    • Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia)
    • Subjects that do not agree to refrain from donating blood while on study drug
    • Concurrent severe or uncontrolled medical disease which by assessment of the treating physician could compromise participation in the study
    • Women during pregnancy and lactation
    • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
    E.5 End points
    E.5.1Primary end point(s)
    1. Recommended dose of MOR00208 in pediatric patients, determined on the basis of the maximum tolerated dose (MTD)
    2. Time until hematological relapse (> 5% leukemic blasts) or increase of MRD ≥ 2 log in bone marrow during an observation time of 545 days accounting for competing risks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. End of Part I.
    2. Day 545.
    E.5.2Secondary end point(s)
    - Pharmacokinetic of MOR00208
    - Safety and toxicity of MOR00208
    - Rate of patients with treatment success defined as survival without newly emerging MRD or increasing MRD ≥ 2 log in bone marrow or peripheral blood or unacceptable toxicity.
    - Overall survival.
    - Rate of patients with MRD reduction of at least 1 log at any time point compared to basline MRD measurement between SCT and start of study treatment.
    - B cell numbers at several time points.
    - Cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts at several time points.
    - Safety and toxicity of MOR00208
    Safety endpoints:
    • Any toxicity irrespective of grade
    • Number of Deaths
    • Number of Relapses
    • Adverse events will be presented in line listings and also in cumulative tabulations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 365 for the rate of patients with treatment success. Day 545 for the other endpoints.
    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 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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First in pediatric patients.
    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 concerned10
    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
    The end of the study is defined as the completion of the trial report.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 39
    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: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) No
    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 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 state39
    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 be carefully monitored according to the centers policy. In general, 1-2 visits per year will be carried out until 10 years after allogeneic stem cell transplantation. Clinical status and remission status will be assessed.
    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 Decision2022-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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