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    Summary
    EudraCT Number:2020-004749-35
    Sponsor's Protocol Code Number:202000671
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-29
    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 number2020-004749-35
    A.3Full title of the trial
    A phase 2 immunoPET imaging study with ZED88082A/CED88004S in patients with Large B-cell lymphoma before and after CD19-directed CAR T-cell therapy
    Een fase 2 immunoPET-beeldvormingsonderzoek met ZED88082A / CED88004S bij patiënten met grootcellig B-cellymfoom voor en na CD19-gerichte CAR T-celtherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CD8 PET imaging study before and after CAR T-cell therapy
    CD8 PET-beeldvormingsonderzoek voor en na CAR T-celtherapie
    A.4.1Sponsor's protocol code number202000671
    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 Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportGenentech Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointTrial Data Center
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503610468
    B.5.6E-mailtrialbureauhematologie@onco.umcg.nl
    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 name89Zr-CED88004
    D.3.4Pharmaceutical form Solution 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 INN89ZR-CED88004
    D.3.9.3Other descriptive name89ZR-CED88004
    D.3.9.4EV Substance CodeSUB193553
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37
    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 Yes
    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.IMP: 2
    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 nameCED88004S
    D.3.4Pharmaceutical form Solution 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 INNCED88004S
    D.3.9.3Other descriptive nameCED88004S
    D.3.9.4EV Substance CodeSUB193547
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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
    Patients with relapsed/refractory LBCL after 2 prior lines of therapy and qualify for CD19-directed CAR T-cell therapy. Eligibility for CAR T-cell therapy is based on the criteria posed by the Dutch Immune Effector Cell working group tumor board.
    Patiënten met recidiverende / refractaire LBCL na 2 eerdere therapielijnen en komen in aanmerking voor CD19-gerichte CAR T-celtherapie. Geschiktheid voor CAR T-celtherapie is gebaseerd op de criteria van de Nederlandse Immune Effector Cell werkgroep tumor board.
    E.1.1.1Medical condition in easily understood language
    Patients with relapsed/refractory LBCL after 2 prior lines of therapy and qualify for CD19-directed CAR T-cell therapy.

    Patiënten met recidiverende / refractaire LBCL na 2 eerdere therapielijnen en komen in aanmerking voor CD19-gerichte CAR T-celtherapie.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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
    The objective is to study the distribution of CD8+ T-cells before and after CAR T-cell therapy in the patient by ZED88082A/CED88004S-PET imaging. We will correlate the pretreatment CD8+ T-cell distribution and CD8+ CAR T-cell tumor invasion, as measured by the intensity of ZED88082A/CED88004S-PET imaging positive lesions.
    Het doel is om de distributie van CD8 + T-cellen voor en na CAR T-celtherapie bij de patiënt te bestuderen door middel van ZED88082A / CED88004S-PET beeldvorming. We zullen de CD8 + T-cel distributie van voorbehandeling en CD8 + CAR T-cel tumorinvasie correleren, zoals gemeten door de intensiteit van ZED88082A / CED88004S-PET beeldvorming van positieve laesies.
    E.2.2Secondary objectives of the trial
    • To assess heterogeneity of ZED88082A/CED88004S tumor uptake.
    • To correlate normal organ ZED88082A/CED88004S uptake to (serious) adverse events (possibly) related to CAR T-cell treatment.
    • To correlate tumor ZED88082A/CED88004S uptake with tumor and immune cell CD8-expression as assessed by a fresh contemporaneous tumor biopsy.
    • To correlate ZED88082A/CED88004S uptake in irradiated versus non-irradiated lymphoma lesions in patients who require radiotherapy as bridging strategy prior to CAR T-cell infusion.
    • De heterogeniteit van de opname van ZED88082A / CED88004S-tumoren beoordelen.
    • Om de opname van ZED88082A / CED88004S in normale organen te correleren met (ernstige) bijwerkingen (mogelijk) gerelateerd aan CAR T-celbehandeling.
    • Om de opname van tumor ZED88082A / CED88004S te correleren met CD8-expressie van tumor en immuuncel, zoals beoordeeld door een nieuwe gelijktijdige tumorbiopsie.
    • Om de opname van ZED88082A / CED88004S in bestraalde versus niet-bestraalde lymfoomlaesies te correleren bij patiënten die radiotherapie nodig hebben als overbruggingsstrategie voorafgaand aan CAR T-cel-infusie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with histologically confirmed LBCL and subtypes according to the WHO 2016 criteria
    2. Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
    3. Measurable disease, as defined by Lugano criteria.
    4. Signed informed consent.
    5. Age ≥18 at the time of signing informed consent.
    6. Life expectancy ≥12 weeks.
    7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    8. Ability to comply with the protocol.
    9. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).
    1. Proefpersonen met histologisch bevestigde LBCL en subtypen volgens de WHO 2016-criteria
    2. Tumorlaesie (s) waarvan veilig een histologische biopsie kan worden verkregen volgens standaard klinische zorgprocedures.
    3. Meetbare ziekte, zoals gedefinieerd door de criteria van Lugano.
    4. Ondertekende geïnformeerde toestemming.
    5. Leeftijd ≥18 op het moment van ondertekening van geïnformeerde toestemming.
    6. Levensverwachting ≥12 weken.
    7. Prestatiestatus Eastern Cooperative Oncology Group (ECOG) 0-1
    8. Vermogen om het protocol na te leven.
    9. Voor vrouwelijke patiënten in de vruchtbare leeftijd en mannelijke patiënten met partners in de vruchtbare leeftijd, de overeenkomst (door de patiënt en / of partner) om een zeer effectieve vorm (en) van anticonceptie te gebruiken (dwz een vorm die resulteert in een laag percentage mislukkingen [< 1% per jaar] bij consistent en correct gebruik).
    E.4Principal exclusion criteria
    1. Signs or symptoms of infection within 2 weeks prior to ZED88082A/CED88004S injection.
    2. Prior immune checkpoint inhibitor bi-specific antibody, including but not limited to anti-PD1 and anti- PD-L1 therapeutic antibodies.
    3. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
    4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ZED88082A/CED88004S, or that may affect the interpretation of the results or render the patient at high risk from complications.
    5. Pregnant or lactating women.
    1. Tekenen of symptomen van infectie binnen 2 weken voorafgaand aan de injectie met ZED88082A / CED88004S.
    2. Eerder bi-specifiek antilichaam van immuuncontrolepuntremmer, inclusief maar niet beperkt tot therapeutische antilichamen tegen PD1 en tegen PD-L1.
    3. Geschiedenis van ernstige allergische, anafylactische of andere overgevoeligheidsreacties op chimere of gehumaniseerde antilichamen of fusie-eiwitten.
    4. Elke andere ziekte, metabole disfunctie, bevinding van lichamelijk onderzoek of klinische laboratoriumbevindingen die een redelijk vermoeden geven van een ziekte of aandoening die een contra-indicatie vormt voor het gebruik van ZED88082A / CED88004S, of die de interpretatie van de resultaten kunnen beïnvloeden of de patiënt in gevaar brengen van complicaties.
    5. Zwangere of zogende vrouwen.
    E.5 End points
    E.5.1Primary end point(s)
    - To determine the whole-body biodistribution of the ZED88082A tracer in normal tissues and tumor lesions before and after CAR T-cell therapy. Heterogeneity of ZED88082A/CED88004S uptake evaluated by measuring standardized uptake value (SUV) on the ZED88082A/CED88004S-PET scan 2 days after ZED88082A/CED88004S injection.
    - Bepalen van de biologische verdeling van de ZED88082A-tracer over het hele lichaam in normale weefsels en tumorlaesies voor en na CAR T-celtherapie. Heterogeniteit van de ZED88082A / CED88004S-opname geëvalueerd door het meten van gestandaardiseerde opnamewaarde (SUV) op de ZED88082A / CED88004S-PET-scan 2 dagen na ZED88082A / CED88004S-injectie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day -13 and +5,
    whereas Day 0 is day of CarT infusion
    Dag -13 en +5, waarbij dag 0 dag van CAR T infusie is
    E.5.2Secondary end point(s)
    - Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, CD8 expression in tumor biopsy, and response to CAR T-cell therapy (see 10.2.1 for efficacy measurements).
    - To perform correlative expression analysis between SUV parameters ZED88082A tracer in the tumor, CD8 expression in tumor biopsy, and SUV parameters the tumor and whole-body and CAR T-cell persistence, peak level and CAR T-cell phenotype as measured in the peripheral blood. Immune cell CD8 expression and tumor and immune cell PD-L1 expression analyses, as well as evaluation of other markers of lymphocytic infiltration in a tissue biopsy, will be correlated to ZED88082A tumor uptake, evaluated by measuring standardized uptake value (SUV parameters on the ZED88082A/CED88004S-PET scan 2 days after ZED88082A/CED88004S injection. Correlative expression analysis between ZED88082A tracer max in the tumor, and grade 1-5 adverse events to CAR T-cell therapy, including cytokine release syndrome and neurotoxicity. Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated), changes in vital signs, and exposure to ZED88082A/CED88004S. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0. Serious adverse events, including deaths, will be listed separately and will be summarized. For events of varying severity, the highest grade will be used in summaries. Relevant laboratory tests, including circulating lymphocyte populations and vital signs (heart rate, respiratory rate, blood pressures, and temperature) data will be displayed by time, with grade 3 and 4 values identified, where appropriate.
    - to correlate ZED88082A/CED88004S uptake in lymphoma to infield and outfield radiation therapy in patients receiving radiation therapy that require bridging to CAR T-cell infusion. Assessment of dosimetry, by calculations of radioactivity in Bq or mSv of ZED88082A concentration in tumor target tissue, blood and other organs of interest with regards to injected dose (ID), derived from measurements of SUV parameters on ZED88082A/CED88004S-PET and direct analysis of blood 89Zr-activity.
    - Correlatieve expressieanalyse tussen ZED88082A tracer SUV-parameters in de tumor, CD8-expressie in tumorbiopsie en respons op CAR T-celtherapie (zie 10.2.1 voor werkzaamheidsmetingen).- Om correlatieve expressieanalyse uit te voeren tussen SUV-parameters ZED88082A-tracer in de tumor, CD8-expressie in tumorbiopsie, en SUV-parameters de tumor en het hele lichaam en CAR T-cel persistentie, piekniveau en CAR T-celfenotype zoals gemeten in het perifere bloed. Immuuncel CD8-expressie en tumor- en immuuncel PD-L1-expressieanalyses, evenals evaluatie van andere markers van lymfocytische infiltratie in een weefselbiopsie, zullen worden gecorreleerd aan ZED88082A tumoropname, geëvalueerd door het meten van gestandaardiseerde opnamewaarde (SUV-parameters op de ZED88082A / CED88004S-PET-scan 2 dagen na ZED88082A / CED88004S-injectie. Correlatieve expressieanalyse tussen ZED88082A-tracer max in de tumor en graad 1-5 bijwerkingen van CAR T-celtherapie, inclusief cytokine-afgiftesyndroom en neurotoxiciteit. Veiligheidsbeoordeling door middel van samenvattingen van ongewenste voorvallen, veranderingen in laboratoriumtestresultaten (indien evaluatie geïndiceerd is), veranderingen in vitale functies en blootstelling aan ZED88082A / CED88004S. Gegevens over ongewenste voorvallen zullen worden geregistreerd en samengevat volgens NCI CTCAE v5.0. Ernstige ongewenste voorvallen, inclusief sterfgevallen, worden apart vermeld en worden samengevat. Voor gebeurtenissen van verschillende ernst wordt de hoogste graad gebruikt in samenvattingen. Relevante laboratoriumtests, inclusief luderende circulerende lymfocytenpopulaties en vitale functies (hartslag, ademhalingsfrequentie, bloeddruk en temperatuur) worden weergegeven in de tijd, met graad 3 en 4 waarden geïdentificeerd, waar van toepassing.- om de opname van ZED88082A / CED88004S bij lymfoom te correleren met bestralingstherapie binnen en buiten het veld bij patiënten die bestralingstherapie krijgen die overbrugging naar CAR T-cel-infusie nodig hebben. Beoordeling van dosimetrie, door berekeningen van radioactiviteit in Bq of mSv van ZED88082A-concentratie in tumordoelweefsel, bloed en andere interessante organen met betrekking tot geïnjecteerde dosis (ID), afgeleid van metingen van SUV-parameters op ZED88082A / CED88004S-PET en directe analyse van bloed 89Zr-activiteit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days -35 to -30, -28, -27 to -20, -15, -13, -12, -7, 0, 3, 5,28, 30
    Dagen -35 tot -30, -28, -27 tot -20, -15, -13, -12, -7, 0, 3, 5, 28, 30
    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 No
    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) 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.8.3 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 years1
    E.8.9.1In the Member State concerned months6
    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 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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with incurable disease
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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