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    Summary
    EudraCT Number:2021-000677-89
    Sponsor's Protocol Code Number:CIMJ995A12101
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-11-25
    Trial results View 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 number2021-000677-89
    A.3Full title of the trial
    Phase I, open label, multicenter, dose escalation and expansion study of IMJ995 in Acute Lymphoblastic Leukemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of IMJ995 in kids and adults with Acute Lymphoblastic Leukemia
    A.4.1Sponsor's protocol code numberCIMJ995A12101
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41613241 111
    B.5.5Fax number+41613248 001
    B.5.6E-mailclinicaltrial.enquiries@novartis.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 nameIMJ995
    D.3.2Product code IMJ995
    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 INNNot established
    D.3.9.2Current sponsor codeIMJ995
    D.3.9.3Other descriptive nameIMJ995
    D.3.9.4EV Substance CodeSUB247836
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number60000000 to 180000000
    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
    Acute Lymphoblastic Leukemia
    E.1.1.1Medical condition in easily understood language
    Acute Lymphoblastic Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10024290
    E.1.2Term Leukaemias acute lymphocytic
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to characterize the safety, tolerability and identify the recommended dose (RD) for IMJ995 in pediatric, adolescent and young adult (AYA) ALL. Another primary objective is to evaluate the feasibility of IMJ995 manufacturing process.
    E.2.2Secondary objectives of the trial
    Objective 1: to characterize the safety and tolerability at pediatric RD for IMJ995 in adult ALL (≥30 y.o.)
    Objective 2: to characterize the in vivo cellular kinetics of IMJ995 in peripheral blood, bone marrow and other relevant tissues by flow cytometry and qPCR
    Objective 3: to characterize the incidence and prevalence of immunogenicity (cellular and humoral) to IMJ995
    Objective 4: to assess preliminary antitumor activity of IMJ995 in pediatric and AYA ALL and adult ALL as assessed by Complete Remission (CR)/ Complete Remission with Incomplete Hematological Recovery (CRi) rate and duration of response as per local investigator
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria:
    Confirmed CNS-1 or CNS-2 status without evidence of neurological changes at time of relapse and before screening
    Evidence of CD19 and/or CD22 cell surface expression on B-cell ALL (B-ALL) blasts in bone marrow or peripheral blood by flow cytometry at time of relapse or prior to study entry
    For pediatric, adolescent and young adult ALL patients:
    Relapsed or refractory CD19+ and/or CD22+ ALL after 3 or more lines of treatment OR after allogeneic HCT
    Must have received a CD19-directed CAR-T treatment (with or without blinatumomab), unless prior loss of CD19 cell surface expression or have not been eligible for CD19 directed CAR-T treatment
    For adult ALL patients aged ≥30 years:
    Refractory or relapsed CD19+ and/or CD22+ ALL including at least one of the following:
    • After allogeneic HCT
    • After 2 or more lines of treatment, including blinatumomab and/or inotuzumab
    • Primary refractory disease (defined as failure to achieve a CR at the end of induction chemotherapy)
    • First relapse occurring within 12 months from first remission

    Other protocol defined inclusion criteria apply.
    E.4Principal exclusion criteria
    Key exclusion criteria:
    Allogeneic HCT within 12 weeks prior to screening
    Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy
    Presence of isolated extra-medullary disease, testicular involvement or bulky disease (bulky disease defined as lymph node or extra nodal tumor that measures greater than ten centimeters in any dimension)
    Patients with concomitant genetic syndromes associated with bone marrow failure states, such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded
    Patients with Burkitt’s lymphoma/leukemia (i.e. patients with mature B-ALL, leukemia with B-cell sIg positive and kappa or lambda restricted positivity ALL, with FAB L3 morphology and /or a MYC translocation)

    Other protocol defined exclusion criteria apply.
    E.5 End points
    E.5.1Primary end point(s)
    -Incidence and nature of Dose Limiting Toxicities (DLTs) during the first 28 days after IMJ995 infusion (Dose Escalation part for pediatric and AYA ALL) .
    Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs after IMJ995 infusion
    -Manufacture success rate (defined as number of patients infused with planned target dose divided by total number of patients infused)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    E.5.2Secondary end point(s)
    -Incidence and nature of DLTs during the first 28 days after IMJ995 infusion (safety cohort for adult ALL)
    -Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs after IMJ995 infusion.
    -Flow cytometry to quantify mono (CAR22+ or CAR19+) and double positive (CAR22+ and CAR19+) expressed T cells over time
    -qPCR to quantify IMJ995 transgene over time in peripheral blood
    -Cellular kinetics parameters: Cmax, Tmax, Area Under the Curve (AUC), Clast, Tlast, and/or other relevant parameters in peripheral blood
    -Summary of pre-existing and treatment induced immunogenicity (cellular and humoral) to CAR19 and/or CAR22.
    -CR/ CRi by day 28 and, 3, 6 and 12 months as per local investigator
    -DoR defined as time from achievement of CR or CRi after IMJ995 infusion and subsequent relapse or death due to the underlying disease.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    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 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
    tolerability
    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) No
    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 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 EEA5
    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
    Canada
    United States
    France
    Netherlands
    Spain
    Germany
    Italy
    United Kingdom
    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 study or Last Patient Last Visit (LPLV) is when all patients have completed at least Month 24 evaluation or died earlier or were withdrawn prematurely, or the study is terminated early. After LPLV, patients will be followed under a separate LTFU protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 22
    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: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 11
    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: 2
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 35
    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)
    Safety follow-up (as per protocol section 9.2.2) and Long-term follow-up (as per protocol section 9.2.3).
    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 Decision2022-11-18
    N.Ethics Committee Opinion of the trial applicationWithdrawn
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-14
    P. End of Trial
    P.End of Trial Status
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