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    Summary
    EudraCT Number:2021-002008-11
    Sponsor's Protocol Code Number:IMC-M113V-103
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-002008-11
    A.3Full title of the trial
    An open-label dose-escalation study evaluating the safety, pharmacokinetics and antiviral activity of IMC-M113V in
    HLA-A*02:01-positive subjects with chronic HIV infection who are virologically suppressed
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of IMC-M113V in virologically suppressed chronic HIV infection
    A.4.1Sponsor's protocol code numberIMC-M113V-103
    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 SponsorImmunocore Limited
    B.1.3.4CountryUnited Kingdom
    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 supportImmunocore Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunocore, Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs Group
    B.5.3 Address:
    B.5.3.1Street Address92 Park Drive, Milton Park
    B.5.3.2Town/ cityAbingdon, Oxfordshire
    B.5.3.3Post codeOX14 4RY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441235438 600
    B.5.6E-mailregaffairsgroup@immunocore.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 nameIMC-M113V
    D.3.2Product code IMC-M113V
    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 INNIMC-M113V
    D.3.9.2Current sponsor codeIMC-M113V
    D.3.9.3Other descriptive nameBispecific protein with a high-affinity T cell receptor domain fused to an antibody single-chain variable fragment against CD3
    D.3.9.4EV Substance CodeSUB234644
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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
    Chronic HIV infection
    E.1.1.1Medical condition in easily understood language
    HIV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1: Single Ascending Dose (SAD) Study
    To evaluate the safety and tolerability of M113V when administered as a single dose during ART
    Part 2: Multiple Ascending Dose (MAD) Study
    To evaluate the safety and tolerability of IMC-M113V when administered in a multiple dose schedule, up to at least week 12, in participants receiving ART
    E.2.2Secondary objectives of the trial
    •To characterise the pharmacokinetic (PK) profile of IMC-M113V in single dose and multiple dose schedules
    •To evaluate incidence of anti-IMC-M113V antibody formation following single and multiple infusions.
    •To determine pharmacodynamic (PD) changes in the systemic immune response in relation to treatment with IMC-M113V, including but not limited to changes in peripheral cytokines and lymphocyte counts
    •To determine the incidence and duration of post-treatment control during analytical therapy interruption in participants completing multiple dose schedules
    •To determine the recommended Phase 2 dosing regimen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. 18-65 years inclusive, at time of informed consent HLA
    2. HLA-A*02:01-positive (central laboratory testing) Weight
    3. ≥ 50 kg
    Condition Under Study and Prior Therapy
    4. Documented evidence of HIV-1 infection
    5. On continuous ART for a minimum of 12 months and maximum of 7 years at the time of planned first dose
    6. Plasma HIV RNA < 50 copies/mL at Screening and at all available determinations in the 12-month period preceding Screening
    7. Current CD4+ T cell count > 500 cells/μL
    8. CD4+ T cell nadir > 200 cells/μL
    Contraception
    9. Participants who engage in sexual activity which could result in pregnancy for themselves or their partner(s) must agree to use highly effective methods of contraception from the trial Screening date until 3 months after the final dose of the study intervention or longer if required by local regulations; cessation of contraception after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 10.4.
    a. Participants are not allowed to donate sperm from the time of enrolment until 3 months post-administration of study interventions or longer if required by local regulations.
    b. Participants must refrain from egg donation during the study.
    Informed Consent
    10. Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Condition Under Study and Prior/Current Antiretroviral Therapy
    1. Known HIV controller: pVL < 2000 copies/mL in absence of ART for at least 12 months and on ≥ 2 determinations.
    2. Initiated ART within 12 weeks of a diagnosis of primary HIV infection, confirmed by any of the following:
    a. Positive HIV-1 serology ≤ 12 weeks after a documented negative HIV-1 antibody (Ab) test,
    b. Negative HIV Ab test plus either positive p24 antigen (Ag) test or detectable HIV RNA,
    c. HIV-1 Ab avidity test consistent with recent infection, or
    d. Weakly reactive or equivocal 4th generation HIV Ab/Ag test.
    3. Prior AIDS-defining condition will preclude participation in Part 1 if diagnosed within 90 days prior to Screening. A prior AIDS-defining condition at any time will preclude participation in Part 2.
    4. Individuals receiving an ART regimen containing a non-nucleoside reverse transcriptase inhibitor may not enrol in Part 2 unless willing and able to switch to a short-acting alternative prior to receiving their first dose of study drug.
    Medical Conditions
    5. Co-infection with HBV (defined as positive HBsAg test or detectable HBV DNA) or HCV infection (defined as detectable HCV RNA).
    6. Current active Mycobacterium tuberculosis infection or known untreated latent infection.
    7. History of clinically significant cardiovascular disease or impaired cardiac function, including any of the following:
    a. Congestive heart failure (New York Heart Association Class ≥3).
    b. Uncontrolled hypertension (consistent findings of systolic blood pressure [BP] >160 mmHg or diastolic BP >110 mmHg, as defined in Section 8.5.2).
    c. History of ventricular arrhythmia currently requiring medical treatment or uncontrolled atrial fibrillation.
    d. QTcF > 470 msec on Screening electrocardiograms (ECGs) or known history of congenital prolonged QT syndrome.
    e. Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to Screening.
    8. Active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn’s disease), within 5 years of screening.
    9. Participants with prior solid organ or bone marrow transplant.
    10. History of malignant disease will preclude participation if diagnosed in the preceding 2 years from the planned first dose of IMC-M113V; in addition, history of systemic virus-associated cancer, including Kaposi’s sarcoma and lymphoma, will preclude participation in Part 2 if diagnosed at any time.
    Prior/Concomitant Therapy
    11. Pregnant or lactating women.
    12. Use of blood products, cytokine therapy or other immunotherapy or immunosuppressive medication in the preceding 3 months from Screening.
    13. Current or recent systemic steroid therapy (in the preceding 3 months from screening) or anticipated need for systemic steroids during the study with the following
    exceptions:
    a. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent.
    b. Local steroid therapies (eg, optic, ophthalmic, intra-articular, or inhaled medications) are acceptable.
    c. Premedication for allergy to contrast reagent.
    Prior/Concurrent Clinical Study Experience
    14. History of any investigational HIV immunotherapy or vaccine within 6 months of Screening.
    15. Planned receipt of vaccines: live vaccines are not permitted within 28 days, and non-live vaccines within 14 days of planned first administration of IMC-M113V.
    Diagnostic Assessments
    16. Participants must not have received prior treatment with an
    ImmTAC.
    17. Participation in other interventional studies is not permitted during
    the treatment and ATI periods of this study.
    18. If any of the following laboratory exclusion criteria are met, then the site may have the participant retested. If a single value is within ±10% of the listed laboratory exclusion criterion value upon retest, and the value is considered not clinically significant by the physician Investigator, the participant may be considered for enrolment:
    a. Hemoglobin < 120 g/L for participants assigned male at birth; < 110 g/L for participants assigned female at birth
    b. Platelet count < 150 × 109/L
    c. Alanine aminotransferase (ALT) > 3 × ULN (upper limit of normal)
    d. eGFR (Foundation, 2009) < 60 mL/min/1.73 m2 (calculated using CKD-EPI equation, 2009; or measured)
    Other Exclusions
    19. For subjects enrolling in Part 2, inability or unwillingness to adhere to safer sex practices during ART interruption.
    20. Known or suspected hypersensitivity or previous severe reactions to any of the constituents of IMC-M113V, or the drugs used in the pre-medication regimen.
    21. Any medical condition that would, in the investigator’s judgement, interfere with the patient’s participation in the study due to safety concerns, compliance with study procedures or interpretation of study results.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence and severity of treatment-emergent adverse events (TEAEs)
    • Incidence of dose-limiting toxicities (DLTs)
    • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF)
    • Incidence of serious adverse events (SAEs) and AEs leading to treatment interruption, dose reduction, or discontinuation through 28 days after the last infusion of study treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence rates will be used to summarise primary endpoints relating to the incidence of AEs. The denominators for incidence rate calculations will be the Safety Analysis Set (SAF) for participants in the respective part of the study (Part 1 - SAD and Part 2 -MAD) except for summaries of DLTs, which will be based on the SAD DLT evaluable set and MAD DLT evaluable set.
    Numerators will generally be based on TEAEs, which are defined as an AE that occurs after the first dose of investigational product and within 28 days of the last dose of investigational product.
    E.5.2Secondary end point(s)
    •IMC-M113V pharmacokinetics (PK) parameters (eg, AUC, Cmax, Tmax, t1/2) at multiple time points from baseline up to 72 hours post-dose in SAD and MAD (first dose) and after each subsequent dose in MAD studies
    •Incidence of anti-IMC-M113V antibody formation following administration of one or more doses of study drug.
    •Change in serum cytokines/chemokines and peripheral blood lymphocyte counts (absolute values and fold-change) from baseline through 72 hours post-dosing with IMC-M113V in SAD and MAD schedules and during Follow-Up
    •Proportion of participants with pVL < 200 copies/mL 12 weeks after interruption of ART (W24)
    •Proportion of participants resuming ART before W24
    •Duration of post-treatment control (pVL < 200 copies/mL) after interruption of ART
    •Duration of virological suppression (pVL <1000 copies/mL) afterinterruption of ART
    •Identification of at least 1 tolerable dosing regimen for further evaluation in subsequent development
    E.5.2.1Timepoint(s) of evaluation of this end point
    Proportion of participants with pVL < 200 copies/mL 12 weeks after interruption of ART (W24)
    • Proportion of participants resuming ART before W24
    • Duration of post-treatment control (pVL < 200 copies/mL) after interruption of ART
    • Duration of virological suppression (pVL < 1000 copies/mL) after interruption of ART
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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
    Antiviral Activity
    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) 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 trial2
    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 No
    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
    Spain
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 53
    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 Decision2021-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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