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    Summary
    EudraCT Number:2022-003618-35
    Sponsor's Protocol Code Number:PKRPC003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-003618-35
    A.3Full title of the trial
    A Phase 1b/2a dose escalation study to determine the recommended dose, efficacy, and tolerability of mocravimod in patients with large B cell lymphoma treated with a CD19 CAR T therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the best dose, the efficacy, and safety of mocravimod in patients with large B cell lymphoma treated with genetically modified immune cells (CD19 CAR T cells)
    A.4.1Sponsor's protocol code numberPKRPC003
    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 SponsorPriothera S.A.S.
    B.1.3.4CountryFrance
    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 supportPriothera S.A.S.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPriothera S.A.S.
    B.5.2Functional name of contact pointClinical Sciences & Operations
    B.5.3 Address:
    B.5.3.1Street Address57 Avenue Général de Gaulle
    B.5.3.2Town/ citySaint Louis
    B.5.3.3Post code68300
    B.5.3.4CountryFrance
    B.5.4Telephone number+33367510040
    B.5.6E-mailinfo@priothera.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 namemocravimod
    D.3.2Product code KRP203
    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 INNMocravimod
    D.3.9.1CAS number 509088-69-1
    D.3.9.2Current sponsor codeKRP203
    D.3.9.4EV Substance CodeSUB195626
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Patients with large B cell lymphoma treated with a CD19 CAR T therapy
    E.1.1.1Medical condition in easily understood language
    Patients with large B cell lymphoma treated with a CD19 CAR T therapy
    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 HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036710
    E.1.2Term Primary mediastinal large B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b: To establish the recommended phase 2 dose (RP2D) of mocravimod for 12 months of treatment as adjunctive and maintenance treatment in subjects with large B cell lymphoma (LBCL) treated with a CD19 CAR T therapy

    Phase 2a: To assess efficacy
    E.2.2Secondary objectives of the trial
    - To assess the safety of mocravimod treatment as add-on to and maintenance after a CD19 CAR T therapy
    - To assess the efficacy of mocravimod treatment as add-on to and maintenance after a CD19 CAR T therapy
    - To evaluate the pharmacokinetics (PK) of mocravimod and mocravimod-phosphate (P) in blood after single and multiple doses of mocravimod
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. Willing and able to understand the information on the nature, the scope, and the relevance of the study, and to provide voluntary, written informed consent to participate in the study before any study-related procedures
    3. Body weight ≥50 kg
    4. Diagnosis of relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL) or primary mediastinal large B cell lymphoma (LBCL)
    5. Have received 2 or more lines of systemic therapy
    6. Will receive a CD19 CAR T cell therapy according to the European approval status and according to local SoC
    7. Measurable disease. A measurable node must have a longest diameter greater than 1.5 cm. A measurable extranodal lesion should have a longest diameter greater than 1.0 cm.
    8. Eastern Cooperative Oncology Group performance status 0 or 1
    9. Able to swallow oral therapy
    10. Female subjects must not be pregnant or breastfeeding and be:
    a. of non-childbearing potential (postmenopausal [no menses for 12 months without an alternative medical cause] or surgically sterilized [documented hysterectomy,
    bilateral salpingectomy, or bilateral oophorectomy]) or
    b. if of childbearing potential, use a highly effective contraceptive method from screening until at least 6 months after the last mocravimod intake and have a negative pregnancy test at Day 1 (blood test)
    Highly effective contraceptive methods (failure rate less than 1% per year when used consistently and correctly, Clinical Trial Facilitation Group guideline) are:
    i. oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
    ii. oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
    iii. intrauterine device
    vi. intrauterine hormone-releasing system
    v. bilateral tubal occlusion
    vi. vasectomized sexual partner (provided that the partner is the sole sexual partner of the woman of childbearing potential and has received medical assessment of the surgical success)
    vii. sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment)
    Abstinence is only accepted as true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods and withdrawal] is not an acceptable method of contraception).
    11. Male subjects must agree, from Screening until 6 months after the last mocravimod intake, to refrain from donating sperm and use a male condom when having sexual intercourse with a woman of childbearing potential, who is not currently pregnant, and advise her to use a highly effective contraceptive method
    E.4Principal exclusion criteria
    1. Evidence of lymphoma involvement of the heart or cerebral spinal fluid
    2. Prior CD19-directed CAR T therapy
    3. Concurrent severe and/or uncontrolled medical condition
    4. Cardiac dysfunction as unstable ischemic heart disease, myocarditis or cardiomyopathy or New York Heart Association Class II-IV congestive heart failure
    5. Resting heart rate <60 bpm
    6. History of syncope of suspected cardiac origin or history of familial long QT syndrome or known family history of Torsades des Pointes
    7. Require any of the following treatments for cardiac dysfunction:
    • Treatment with medication that impairs cardiac conduction (eg, beta blockers, verapamil-type and diltiazem-type calcium channel blockers, or cardiac glycosides), or
    • Treatment with quinidine.
    8. Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. Hepatic dysfunction as defined by aspartate aminotransferase and/or
    alanine aminotransferase >2.5 x upper limit of normal (ULN); or total bilirubin >1.5 x ULN
    9. Renal dysfunction with estimated creatinine clearance <60 mL/min/1.73m² according to Modification of Diet in Renal Disease
    10. History of human immunodeficiency virus (HIV) or active infection with hepatitis B virus or hepatitis C virus defined as a positive HIV antibody, hepatitis B surface antigen
    or hepatitis C antigen
    11. Diagnosis of any previous or concomitant malignancy, except subjects diagnosed with localized basal cell carcinoma of the skin or in situ cervical cancer, or subjects who have completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for the malignancy at least 3 years prior to enrollment
    12. Pregnant and lactating women
    13. Known hypersensitivity to mocravimod or any of the excipients
    14. Diagnosis of macular edema during Screening. Subjects with a history of macular edema will be allowed to enter the study provided they do not have macular edema at
    the ophthalmic examination at Screening.
    15. Participation in another interventional study within 4 weeks prior to randomization or planned participation in a concomitant interventional clinical study during the treatment phase
    16. Dependent subjects of the sponsor or investigator (eg, employees, relatives)
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b: Recommended phase 2 dose (RP2D) based on safety, pharmacokinetics (PK), and immunomonitoring in phase 1b
    Phase 2a: Progression-free survival (PFS), defined as time from first dose of mocravimod to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to End of study
    E.5.2Secondary end point(s)
    • Adverse events (AEs), including the type, frequency, seriousness, and severity of AEs
    • AEs of special interest (AESIs) and their relationship to mocravimod
    • Overall response rate (ORR), defined by the Lugano response criteria
    • Time to response (TTR), defined as the time from the first dose of mocravimod to the first documented response
    • Duration of response (DOR), defined as time from documentation of response to the first documentation of progression disease (PD)
    • Overall survival (OS), defined as time from first dose of mocravimod to death due to any cause
    • Time to next treatment (TTNT), defined as time from first dose of mocravimod to the date of initiation of the next line of therapy
    • Pharmacokinetics (PK) parameters of mocravimod and mocravimod-P in blood after single and repeated doses of mocravimod
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to End of study
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Proteomics, metabolomics, metagenomics, phenomics and transcriptomics
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation
    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 Yes
    E.8.1.7.1Other trial design description
    Dose escalation
    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
    The end of the study is defined as the date at which the last data point from the last subject is collected, which is defined as the last subject last visit. The study will conclude once the events for the overall survival analysis have been reached and all subjects have been followed up for at least 28 days after the last mocravimod intake.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    After the end-of-treatment visit, subjects will not receive any further study-specific treatment. Mocravimod is an investigational medicinal product under development and will, consequently, not be available for treatment of the subjects after the treatment phase completion, after relapse, or in case of study discontinuation by the subject or the sponsor. After participation, subjects will be managed in accordance with local clinical practice, i.e., as per local guidelines and standard of care.
    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 Decision2023-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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