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    Summary
    EudraCT Number:2021-003272-13
    Sponsor's Protocol Code Number:CP0201-NHL
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-003272-13
    A.3Full title of the trial
    A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the safety and efficacy of 19CP02 in subjects with non-Hodgkin lymphoma
    A.3.2Name or abbreviated title of the trial where available
    Atalanta-1
    A.4.1Sponsor's protocol code numberCP0201-NHL
    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 SponsorCellPoint B.V.
    B.1.3.4CountryNetherlands
    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 supportCellPoint B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCellPoint B.V.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressBioPartner 5, De Limes 7
    B.5.3.2Town/ cityOegstgeest
    B.5.3.3Post code2342 DH
    B.5.3.4CountryNetherlands
    B.5.6E-mailclinops@cellpoint.bio
    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 name19CP02
    D.3.2Product code 19CP02
    D.3.4Pharmaceutical form Dispersion for 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 INNanti-CD19 CAR T cells
    D.3.9.2Current sponsor code19CP02
    D.3.9.3Other descriptive nameCD19 CAR T CELLS
    D.3.9.4EV Substance CodeSUB197555
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 250
    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
    Relapsed/refractory B-cell non-Hodgkin lymphoma
    E.1.1.1Medical condition in easily understood language
    non-Hodgkin lymphoma
    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 HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: Evaluate the safety of 19CP02 and determine the recommended Phase 2 dose
    Phase II: Evaluate the efficacy of 19CP02 in the different NHL subtypes
    E.2.2Secondary objectives of the trial
    1. Evaluate safety of 19CP02
    2. Evaluate efficacy of 19CP02
    3. Evaluate 19CP02 pharmacokinetics
    4. Evaluate 19CP02 pharmacodynamics
    5. Evaluate feasibility of 19CP02 manufacturing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form
    2. Age ≥ 18 years
    3. Histologically confirmed diagnosis of one of the following non-Hodgkin lymphoma subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, or MCL
    4. Relapsed or refractory disease
    5. Measurable disease according to the Lugano classification
    6. ECOG performance status of 0 or 1 (ECOG 2 is allowed if due to underlying disease)
    7. Adequate bone marrow, renal, hepatic and pulmonary function
    E.4Principal exclusion criteria
    1. Primary CNS B-cell lymphoma, Burkitt lymphoma, or Richter’s transformation
    2. Selected prior treatments as defined in the protocol
    3. History of malignancy other than lymphoma (exceptions per protocol)
    4. Active CNS involvement (with neurological changes) by disease under study
    5. Infection with HIV, hepatitis B or hepatitis C virus
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: Incidence of (S)AEs, including dose-limiting toxicities (DLTs) until D28
    Phase II: ORR until 2 years post 19CP02 dose per Lugano classification
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety (including DLTs) and efficacy data are reviewed on a continuous basis throughout the study. After completion of Phase I, safety and efficacy data will be evaluated to determine the RP2D.
    The primary analyses will be conducted when all subjects have completed at least one response assessment. Final study report will be conducted when all subjects have completed the 2 years disease response assessment, are lost to follow‐up, withdraw from the study, or die, whichever occurs first.
    E.5.2Secondary end point(s)
    1. Type, frequency and severity of AEs
    2. Objective response rate (ORR) until 2 years post 19CP02 dose per Lugano classification
    Duration of response (DOR)
    Metabolic complete response rate (mCR)
    Event-free survival (EFS)
    Progression-free survival (PFS)
    Overall survival (OS)
    Minimal Residual Disease (MRD)
    3. Levels of anti-CD19 CAR T cells in blood, bone marrow, CSF, and other tissues, if available
    4. Levels of chemokines and cytokines in serum over time
    5. Number of successfully manufactured 19CP02 products within the predefined release specifications
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analyses will be conducted when all subjects have completed at least one response assessment. Final study report will be conducted when all subjects have completed the study (after LVLS).
    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 Yes
    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
    Immunogenicity
    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) 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 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 EEA3
    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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    Standard of Care, per local institutional 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 Decision2021-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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