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    Summary
    EudraCT Number:2018-000121-32
    Sponsor's Protocol Code Number:68284528MMY2001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-05-16
    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 number2018-000121-32
    A.3Full title of the trial
    A Phase 1b-2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Relapsed or Refractory 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 Relapsed or Refractory Multiple Myeloma
    A.4.1Sponsor's protocol code number68284528MMY2001
    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 +31 71 524 21 66
    B.5.5Fax number+31 71 524 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 Solution 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.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 or Refractory 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 20.0
    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
    1. To characterize the safety of JNJ68284528 and establish the dose (RP2D) (Phase 1b)
    2. To evaluate the efficacy of JNJ-68284528 (Phase 2)
    E.2.2Secondary objectives of the trial
    1. To characterize the safety of JNJ68284528(Phase 2)
    2. To characterize the pharmacokinetics and pharmacodynamics of JNJ-68284528
    3. To assess the immunogenicity of JNJ-68284528
    4. To further characterize the efficacy of JNJ-68284528
    5. To compare the patient-reported outcomes (PRO) after treatment to subject’s reported health state prior to treatment and to assess the sustained benefit of subject’s perceived health related quality of life (HRQoL) (Phase 2 only)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years of age.
    2.Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria.
    3.Measurable disease at Screening as defined by any of the following:
    - Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours; or
    - Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain greater than or equal to 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
    4.Received at least 3 prior multiple myeloma treatment regimens or are double refractory to an IMiD and PI (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
    -Undergone at least 1 complete cycle of treatment for each regimen, unless PD was the best response to the regimen.
    5. Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens).
    6. Subject must have documented evidence of progressive disease based on investigator’s determination of response by the IMWG criteria on or within 12 months of their last regimen. Confirmation may be from either central or local testing. Also, subjects with documented evidence of progressive disease (as above)
    within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible.
    7. ECOG Performance Status grade of 0 or 1
    8. Clinical laboratory values as specified in the protocol
    9. Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of cyclophosphamide and fludarabine using a highly sensitive serum pregnancy test (β human chorionic gonadotropin [β-hCG]).
    10. When a woman is of childbearing potential the following are required:
    -Subject must agree to practice a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agree to remain on a highly effective method of contraception from the time of signing the informed consent form (ICF) until at least 100 days after receiving a JNJ-68284528 infusion.
    -Examples of highly effective contraceptives include:
    - user-independent methods: 1) implantable progestogen-only hormone contraception associated with inhibition of ovulation; 2) intrauterine device; intrauterine hormone-releasing system; 3) vasectomized partner;
    - user-dependent methods: 1) combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral or intravaginal or transdermal; 2) progestogen-only hormone contraception associated with inhibition of ovulation (oral or injectable)
    In addition to the highly effective method of contraception a man:
    -Who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) from the time of signing the ICF until at least 100 days after receiving a JNJ-68284528 infusion
    - Who is sexually active with a woman who is pregnant must use a condom
    Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and for 100 days after the last dose of study treatment.
    Note: Hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the efficacy of the contraceptive method.
    11. Subject must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part
    of standard-of-care for the subject’s disease.
    12. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    E.4Principal exclusion criteria
    1. Prior treatment with CAR-T therapy directed at any target.
    2. Any therapy that is targeted to BCMA.
    3. Diagnosed or treated for invasive malignancy other than multiple myeloma, except:
    -Malignancy treated with curative intent and with no known active disease present for greater than or equal to 2 years before enrollment; or
    -Adequately treated non-melanoma skin cancer without evidence of disease.
    4. Prior antitumor therapy as follows, prior to apheresis:
    -Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half lives, whichever is less
    -Monoclonal antibody treatment for multiple myeloma within 21 days.
    -Cytotoxic therapy within 14 days.
    -Proteasome inhibitor therapy within 14 days.
    -Immunomodulatory agent therapy within 7 days.
    -Radiotherapy within 14 days. However, if the radiation portal covered less than or equal to 5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiotherapy.
    5. Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
    6. The following cardiac conditions:
    -New York Heart Association (NYHA) stage III or IV congestive heart failure
    -Myocardial infarction or coronary artery bypass graft (CABG) less than or equal to 6 months prior to enrollment
    -History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
    -History of severe non-ischemic cardiomyopathy
    -Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to 8 weeks of apheresis).
    7. Received a cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone within the 7 days prior to apheresis
    8. Received either of the following:
    -An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD).
    -An autologous stem cell transplant less than or equal to 12 weeks before apheresis
    9. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
    10. Stroke or seizure within 6 months of signing ICF.
    11. Plasma cell leukemia at the time of screening (>2.0 x 109/L plasma cells by standard differential), Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.
    12. Seropositive for human immunodeficiency virus (HIV).
    13. Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis.
    14. Hepatitis B infection as defined in the protocol. In the event the
    infection status is unclear, quantitative levels are necessary to determine the infection status.
    15. Hepatitis C infection defined as (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA positive) or known to have a history of hepatitis C. For subjects with known history of HCV infection, confirmation of sustained virologic response [SVR] is required for study eligibility, defined as ≥24 weeks after completion of antiviral therapy.
    16. Supplemental oxygen use to maintain adequate oxygenation.
    17. Known life threatening allergies, hypersensitivity, or intolerance to JNJ-68284528 or its excipients, including DMSO.
    18. Serious underlying medical condition, such as:
    -Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection
    -Active autoimmune disease or a history of autoimmune disease within 3 years
    -Overt clinical evidence of dementia or altered mental status
    19. Any issue that would impair the ability of the subject to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    20. Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 100 days after receiving study treatment.
    21. Plans to father a child while enrolled in this study or within 100 days after receiving study treatment.
    22. Major surgery within 2 weeks prior to apheresis, or has surgery planned during the study or within 2 weeks after study treatment administration. (Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.)
    E.5 End points
    E.5.1Primary end point(s)
    1. Phase 1b: Number of Participants with Adverse Events
    2. Phase 1b: Number of Participants with Adverse Events by Severity
    3. Phase 2: Overall Response Rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Minimum 2 years after JNJ-68284528 infusion (Day 1)
    2. Minimum 2 years after JNJ-68284528 infusion (Day 1)
    3. Minimum 2 years after JNJ-68284528 infusion (Day 1)
    E.5.2Secondary end point(s)
    1. Phase 2: Number of Participants with Adverse Events
    2. Levels of B-Cell Maturation Antigen (BCMA) Expressing Cells and Soluble BCMA
    3. Systemic Cytokine Concentrations
    4. Levels of CAR-T Cells
    5. Level of JNJ-68284528 T Cell Expansion (proliferation), and Persistence
    6. Number of Participants with Anti-JNJ68284528 Antibodies
    7. Very Good Partial Response (VGPR) or Better Rate
    8. Percentage of Participants who Achieve Clinical Benefit Rate
    9. Duration of Response (DOR)
    10. Progression-free Survival (PFS)
    11. Overall Survival (OS)
    12. Percentage of Participants With Negative Minimal Residual Disease (MRD)
    13. Time to Response (TTR)
    14. Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by EORTC QLQ-C30
    15. Change from Baseline in HRQoL as Measured by EORTC QLQ-MY20
    16. Change from Baseline in Participant reported Health Status Measured by EQ-5D-5L
    17. Change from Baseline in Global Health Status Using PGIC Scale
    18. Change from Baseline in Pain Measured by PGIS Scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-13: Minimum 2 years after JNJ-68284528 infusion (Day 1)
    14-18: Baseline up to study completion (Minimum 2 years after JNJ-68284528 Infusion on Day 1)
    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
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    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
    The end of the study will be defined as 2 years after the last subject has received his or her initial dose of JNJ-68284528.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months25
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 110
    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 standard
    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 Decision2019-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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