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    Summary
    EudraCT Number:2019-001073-86
    Sponsor's Protocol Code Number:MT-3724_NHL_001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-05-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-001073-86
    A.3Full title of the trial
    Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients with Relapsed or Refractory DLBCL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MT-3724 investigational drug for the treatment of patients with resistant or recurring B-cell cancer
    A.4.1Sponsor's protocol code numberMT-3724_NHL_001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02361346
    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 SponsorMolecular Templates, Inc.
    B.1.3.4CountryUnited States
    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 supportMolecular Templates, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMolecular Templates, Inc.
    B.5.2Functional name of contact pointCorporate Headquarters
    B.5.3 Address:
    B.5.3.1Street Address9301 Amberglen Blvd, Suite 100
    B.5.3.2Town/ cityAustin
    B.5.3.3Post codeTX 78729
    B.5.3.4CountryUnited States
    B.5.6E-mailinfo@MTEM.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.3.2Product code MT-3724
    D.3.4Pharmaceutical form Concentrate for 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 2413852-25-0
    D.3.9.2Current sponsor codeMT-3724
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Yes
    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
    relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
    E.1.1.1Medical condition in easily understood language
    relapsed or refractory lymphoma
    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 PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In Part 3 of this study:
    To evaluate the safety of MT-3724 as monotherapy in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

    In Part 4 of this study:
    To determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the ORR by the Lugano
    Classification for Lymphoma (Cheson BD, 2014)
    E.2.2Secondary objectives of the trial
    In part 3 of the study:
    •To evaluate the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the Lugano Classification for Lymphoma
    •To evaluate additional measures of efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL
    •To evaluate the PK of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL
    •To evaluate the PD of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL
    •To evaluate the immunogenicity of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL

    In part 4 of the study:
    Same as for Part 3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female subjects ≥18 years of age at the time of informed consent.
    •Subjects must have relapsed or refractory diffuse large B-cell lymphoma (DLBCL) according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification [ (Swerdlow SH, 2016)]. Subjects must have proof of CD20+ DLBCL, based on either:
    a. historical biopsies (obtained with diagnosis of relapsed or refractory
    disease), or
    b. fresh biopsies
    c. bone marrow biopsy, excisional lymph node biopsy, and core biopsy of any involved organ are all acceptable methods; Fine Needle Aspirate (FNA) is not acceptable.
    NOTE: Composite lymphoma (DLBCL and indolent histology in the same specimen) is also acceptable.
    •Subjects must have received at least 2 standard of care regimens (including anti-CD20 antibody therapy) for NHL treatment.
    a. Subjects whose prior therapy includes chimeric antigen receptor T-cell (CAR-T) therapy are eligible.
    b. Subjects who underwent stem cell transplant (SCT) >100 days for autologous SCT or >180 days for allogeneic SCT before study drug administration and exhibited a full hematological recovery (consistent with the existing inclusion criteria requirements and without peripheral red blood cell [PRBC] or platelet transfusions within 2 weeks of C1D1) prior to relapse are eligible.
    c. Subjects who have been ineligible for standard of care NHL treatment(s) may be eligible at the investigator's discretion, upon sponsor approval.
    •Subjects must have at least 1 bi-dimensional tumor lesion at screening that is measurable by CT or MRI according to the Lugano criteria [(Cheson BD, 2014)]. Bi-dimensionally measurable tumor lesion by CT/MRI is defined as longest diameter of >1.5 cm for lymph nodes and >1.0 cm for extranodal disease.
    •Subjects must have life expectancy of >3 months from the start of treatment.
    E.4Principal exclusion criteria
    Subjects who meet ANY of the following criteria must be excluded:
    • Received any amount of anti-CD20 mAbs within the following periods before the start of treatment:
    a. Rituximab (Rituxan®/MabThera® or rituximab biosimilar): within 84 days (12 weeks); if a subject has received rituximab within 37 weeks before the start of treatment, then serum rituximab level must be negative (<500 ng/mL) at screening.
    b. Obinutuzumab (Gazyva®/Gazyvaro®): 184 days.
    c. Ofatumumab (Arzerra®): 88 days.
    • Received approved or investigational treatment for NHL (except anti- CD20 mAbs and radioimmunoconjugates) within 4 weeks before the start of treatment. For small molecules (MW <0.9 kDa), the washout is 5 half-lives or at least 2 weeks. Radioimmunoconjugates are excluded within 12 weeks before the start of treatment.
    •Current evidence of hypersensitivity or other underlying illness requiring systemic corticosteroids at doses >20 mg/day prednisone equivalent
    •Current evidence of uncontrolled HIV, HBV or HCV at screening.
    Serology testing is not required if seronegativity is documented in the medical history, and if there are no clinical signs suggestive of HIV or hepatitis infections, or suspected exposure. The following exceptions apply for subjects with positive viral serology:
    a. Subjects with HIV and an undetectable viral load and CD4+ T-cell (CD4+) counts ≥ 350 cells/mL may be enrolled, but must be taking appropriate opportunistic infection prophylaxis, if clinically relevant.
    b. Subjects with positive HBV serology are eligible if they have an undetectable viral load and the subject will receive antiviral prophylaxis for potential HBV reactivation per institutional guidelines.
    c. Subjects with positive HCV serology are eligible if quantitative PCR for plasma HCV RNA is below the lower limit of detection. Concurrent antiviral HCV treatment per institutional guidelines is allowed.
    •History of cardiovascular, renal, hepatic or any other disease within ≤3 months before the start of treatment that in the investigator's opinion, may increase the risks associated with study participation or require treatments that may interfere with the conduct of the study or the interpretation of study results.
    •History or current evidence of neoplastic disease that is histologically distinct from NHL, except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer. Subjects with prior, curatively treated cancer >2 years ago before the start of treatment can be enrolled.
    • Current evidence of new or growing brain or spinal metastases during screening. Subjects with known brain or spinal metastases may be
    eligible if they:
    a. Had radiotherapy or another appropriate therapy for the brain or spinal metastases; concurrent prophylactic treatment is allowed
    b. Neurologic symptoms must be stable and no worse than Grade 2
    c. Have evidence of stable brain or spinal disease on CT or MRI scan obtained within 4 weeks before signing the informed consent and compared with prior imaging results
    d. Do not require steroid therapy (or, if applicable, have been stable on dose of no more than prednisone 20 mg/day or equivalent by C1D1)
    E.5 End points
    E.5.1Primary end point(s)
    Part 3:
    • adverse events
    • laboratory abnormalities
    • vital signs
    Part 4:
    • overall response rate is defined as the proportion of subjects with either a CR or a PR as determined by independent, blinded central review
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 3: Ongoing up until 30 days +/- 3 days
    Part 4: Every 6 weeks until death, disease progression or loss to follow-up.
    For subjects without response or stable disease at EoT: within 7 days of the EoT Visit (only if the previous tumor scan has been performed greater than 4 weeks before the EoT Visit)
    E.5.2Secondary end point(s)
    Part 3:
    • ORR is defined as the proportion of subjects with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review
    • ORR, defined as the proportion of subjects with either a CR or a PR as determined by investigator assessment
    • duration of tumor response (DOR), defined as time from initial documentation of tumor response (CR or PR) to disease progression
    • disease control rate (DCR), defined as proportion of subjects who have achieved CR, PR and stable disease (SD; defined as SD for 6 months or longer)
    • PK parameters, where calculable, include: maximum observed plasma concentration (Cmax), time to achieve Cmax (tmax), and area under the plasma concentration time curve from 0 to 4 hours (AUC0-4), AUC from 0 to infinity (AUC0-inf), AUC from dosing to last measurable concentration (AUClast), half-life (t1/2), volume of distribution (Vz), and clearance (CL)
    • B-cell count
    • immunophenotyping
    • incidence of anti-drug antibodies
    Part 4:
    Key secondary: DOR, defined as time from initial documentation of tumor response (complete response [CR] or partial response [PR]) to disease progression
    • adverse events
    • laboratory abnormalities
    • vital signs
    • electrocardiograms (ECGs)
    • adverse events suggestive of cardiotoxicity
    • overall response rate (ORR), defined as the proportion of subjects with either a CR or a PR as determined by investigator assessment
    • disease control rate (DCR), defined as proportion of subjects who have achieved CR, PR and SD (defined as SD for 6 months or longer)
    • progression-free survival (PFS), defined as the time from study enrollment to the earliest date of disease progression or death from any cause.
    • overall survival (OS), defined as the time from study enrollment to death from any cause
    • PK parameters, where calculable, include: Cmax, tmax, AUC0-4, AUC0- inf, AUClast, t1/2, Vz and CL
    • B-cell count
    • immunophenotyping
    • incidence of anti-drug antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Short-term Safety Follow Up: 30 days (±3) after last dose of MT-3724
    • Long-term Follow Up: Every 3 months (±14 days) after the last dose of MT-3724 for up to 18 months from the last dose.
    • Progression-free survival (PFS): Time from study enrollment to the earliest date of disease progression or death from any cause: up to 18 months after the last dose of MT-3724
    • Overall survival (OS): Time from study enrollment to death from any cause: up to 18 months after the last dose of MT-3724
    • Duration of tumor response (DOR): Time from initial documentation of tumor response (CR or PR) to disease progression: up to 18 months after the last dose of MT-3724
    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 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.8.2.4Number 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 EEA20
    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
    Argentina
    Australia
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    Germany
    Israel
    Italy
    Malaysia
    Moldova, Republic of
    Poland
    Romania
    Serbia
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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 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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 108
    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
    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 Decision2020-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-02
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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