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    Summary
    EudraCT Number:2018-004124-10
    Sponsor's Protocol Code Number:68284528MMY2003
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-11-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-004124-10
    A.3Full title of the trial
    A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open Label Study of JNJ-68284528, Directed Against BCMA in Subjects with Multiple Myeloma
    A.4.1Sponsor's protocol code number68284528MMY2003
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3171524 21 66
    B.5.5Fax number+3171524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameJNJ-68284528
    D.3.2Product code JNJ-68284528
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeJNJ-68284528
    D.3.9.3Other descriptive nameJNJ-68284528
    D.3.9.4EV Substance CodeSUB197280
    D.3.10 Strength
    D.3.10.1Concentration unit kg kilogram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1.0
    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) Yes
    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 numberThe EMA/CAT considers that product JNJ-68284528, falls within the definition of gene therapy medicinal product. Product ref.: H0005095
    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 Yes
    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.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 Yes
    D.2.1.1.1Trade name REVLIMID
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    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 namelenalidomide
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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
    Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of JNJ-68284528
    -To further characterize MRD negativity
    -To characterize the safety of JNJ-68284528
    -To characterize the pharmacokinetics and pharmacodynamics of JNJ-68284528
    -To assess the immunogenicity of JNJ-68284528
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort A:
    -1-3 prior lines of therapy, including PI and IMiD
    -Lenalidomide refractory
    -Anti-CD38 mAb exposure not required
    -PD per IMWG criteria ≤6 months of last regimen; confirmation may be either central or local
    -Prior SCT allowed (allo: >6 months before apheresis; auto: >12 weeks before apheresis)

    Cohort B:
    -Frontline therapy with PI and IMiD
    -Transplant and non-transplant patients
    -Anti-CD38 mAb exposure not required
    -PD per IMWG criteria ≤12 months of:
    a. Autologous SCT
    b. Start of initial therapy (non-transplanted patients)

    Cohort C:
    -Previously treated with PI, IMiD, anti-CD38 mAb and BCMA-directed therapy (as monotherapy or in combination)
    a. Irrespective of dose level or response to prior BCMA-directed therapy
    -PD per IMWG criteria
    a. ≤12 months of last line of therapy
    b. ≤6 months of prior therapy, and refractory or non-responsive to their most recent line of therapy

    Cohort A, B, C:
    Measurable disease at Screening as defined by any of the following:
    -Serum M-protein ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    -Light chain MM without measurable disease in serum or urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
    -Central screening lab results required for all study patients:
    Local laboratory assessments may be used to establish measurable disease at Screening, with local laboratory result ≥125% of requirements
    -Lab values as defined in the protocol

    Cohort D:
    -Newly diagnosed MM per IMWG with 4 to 8 total cycles of initial therapy, including induction, high-dose therapy and ASCT with or without consolidation
    a. Previously treated for smoldering myeloma not eligible
    b. Patient treated with consolidation must have received ≤2 cycles
    - Received IMiD or PI or both in combination with steroid as part of induction or consolidation regimen
    -Tx with alkylating therapy (eg, cyclophosphamide) or mAb during induction/ consolidation permitted
    -Labs as specified in the protocol
    For a full list of inclusion criteria, please refer to the protocol, pg 60-78.
    E.4Principal exclusion criteria
    Key Exclusion criteria (All cohorts):
    -Antitumor treatment washout prior to apheresis
    -Toxicity from previous anticancer therapy must have resolved to baseline or ≤Grade 1 except alopecia or peripheral neuropathy
    - Serious underlying medical condition, eg:
    a.Clinically significant cardiac conditions (CHF, MI, LVEF <45%)
    b. Active / Hx of autoimmune disease within 3 yrs
    c. Dementia or altered mental status
    d. Serious viral, bacterial or uncontrolled systemic fungal infection 
    e. Seropositive for HIV
    f. Clinically significant Hepatitis B or C infection
    - Cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone ≤7 days prior to apheresis
    - Stroke or seizure ≤6 months
    - Pregnant, breast-feeding or planning to become pregnant / father child while enrolled in study and until 1 year after receiving a JNJ-68284528 infusion
    a.Cohort D: Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study
    and until 1 year after receiving a JNJ-68284528 infusion or for 4 weeks following discontinuation of lenalidomide (whichever is later).

    For a full list of exclusion criteria, please refer to the protocol, pg 63-81.
    E.5 End points
    E.5.1Primary end point(s)
    MRD negative rate at a 10-5 threshold as defined by the International Myeloma Working Group (IMWG) criteria using next generation sequencing (NGS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately at 1 year after the last subject for each individual cohort has received his or her initial dose of JNJ-68284528
    E.5.2Secondary end point(s)
    -Overall Response Rate (ORR) (partial response [PR] or better) as defined by the IMWG response criteria
    -VGPR, CR, sCR rate as defined by the IMWG response criteria, clinical benefit rate (CBR; CBR = ORR [sCR + CR + VGPR + PR] + minimal response [MR])
    -Duration of response (DOR) and time to response (TTR)
    -MRD negative rate at 12 months for subjects who achieved a complete response (CR MRD neg 12
    month)
    -Time to MRD negativity, duration of MRD
    negativity,
    -MRD negative rate across clinical response groups
    (CR, stringent complete response [sCR], very good partial response [VGPR])
    -Incidence and severity of adverse events, laboratory results, and other safety parameters
    -Pharmacokinetic and pharmacodynamic markers
    including but not limited to depletion of soluble
    BCMA and BCMA expressing cells, systemic
    inflammatory cytokine concentrations and immune
    related proteins, and markers of CAR-T cell activation, expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level.
    -Presence of anti- JNJ-68284528 antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cohorts A, B, and C will be considered complete after the last subject has had two years of follow-up after the initial dose of JNJ-68284528. Cohort D will be considered complete after the last subject has discontinued lenalidomide for 4 weeks or 2 years after receiving the initial dose of JNJ-68284528, whichever is later.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenecity
    Biomarker
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Israel
    Netherlands
    Spain
    United States
    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
    Cohorts A, B, and C will be considered complete after the last subject has had 2 years of follow-up after the initial dose of JNJ-68284528. Cohort D will be considered complete after the last subject has discontinued lenalidomide for 4 weeks or 2 years after receiving the initial dose of JNJ-68284528, whichever is later.
    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 months1
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days30
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 80
    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)
    Following completion of this study, assessment for replication competent lentivirus (RCL) and secondary primary malignancies will be collected yearly until 15 years after the last dose with JNJ-68284528 on a follow-up study.
    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 Decision2020-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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