Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-000801-28
    Sponsor's Protocol Code Number:MSB-IG-H-2101
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-25
    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 - PEI
    A.2EudraCT number2022-000801-28
    A.3Full title of the trial
    Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients with Relapsing Remitting Multiple Sclerosis
    Multizentrische Phase-Ib/IIa-Studie zur Sicherheit und Wirksamkeit von autologen peptidgekoppelten roten Blutkörperchen bei Patienten mit schubförmig remittierender Multipler Sklerose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    RED4MS
    A.4.1Sponsor's protocol code numberMSB-IG-H-2101
    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 SponsorCellerys 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 supportCellerys AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCellerys AG
    B.5.2Functional name of contact pointAdministrative Office
    B.5.3 Address:
    B.5.3.1Street AddressWagistrasse 21
    B.5.3.2Town/ citySchlieren
    B.5.3.3Post code8952
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41415449880
    B.5.6E-mailinfo@cellerys.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 nameCLS12311
    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 applicable
    D.3.9.2Current sponsor codeCLS12311
    D.3.9.3Other descriptive namePeptid coupled red blood cells
    D.3.9.4EV Substance CodeSUB15114MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.2E11 to 3.5E11
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAutologous red blood cells coupled with 12 peptides
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Remitting Multiple Sclerosis (RRMS)
    E.1.1.1Medical condition in easily understood language
    Diagnosis of relapsing-remitting multiple sclerosis (RRMS). In this type of MS, flare-ups of the disease occur. Between these flare-ups, there are periods of recovery or remission.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety objective (Part A and B)
    To assess the safety and tolerability of CLS12311 in patients with RRMS

    Efficacy objective (Part B)
    To provide proof-of-concept for the efficacy of CLS12311 in reducing the number of new lesions on brain magnetic resonance imaging (MRI) as a measure for inflammatory disease activity in patients with RRMS
    E.2.2Secondary objectives of the trial
    Safety objectives (Part A and B)
    To assess the safety and tolerability of each dose group of CLS12311

    Efficacy objective (Part B)
    To define the optimal dose of CLS12311 to reduce new disease activity on brain MRI in RRMS patients

    Exploratory objective (Part A and B)
    To understand the mechanism/s of action of tolerance induction with peptide-coupled RBCs and to identify biomarkers for measuring immune tolerance induction
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A and Part B
    General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history):
    1. RRMS according to the 2017 McDonald criteria
    2. Male or female patients (assigned at birth) aged 18-55 years
    3. Disease duration (since diagnosis) <10 years
    4. EDSS at baseline 0-5.5
    5. ≥1 relapse or new CEL/T2 in previous 12 months (only Part B)
    6. Untreated patients or patients being off therapy for the time periods listed under exclusion criterion No. 2. Patients are either not eligible to receive approved therapies or have explicitly chosen not to receive such therapies after being adequately informed by the investigators
    7. Only for sexually active female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a highly effective method of contraception (defined in the study protocol) throughout the complete treatment phase or at least for 4 weeks after the last dose of CLS12311
    8. Male patients willing to use contraception (condoms) throughout the complete treatment phase or at least for 4 weeks after the last dose of CLS12311 unless surgically sterile
    9. Basic immunization against SARS-CoV-2, i.e. both doses of two-dose vaccines (or one dose of a vaccine and a SARS-CoV-2 infection before or after vaccination) OR a dose of a single-dose vaccine

    Part B
    Specific qualification criteria (to be assessed during the baseline period):
    10. ≥ 2 cumulative new brain lesions (as defined above) on two MRI scans performed during baseline phase
    E.4Principal exclusion criteria
    Part A and B
    General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history):
    1. Patients with an active chronic disease (or stable but treated with immunomodulatory/-suppressive therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Crohn’s disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency)
    2. Prior treatment with any of the medications below within the specified time-frame:
    a. glatiramer acetate, interferon-beta within 4 weeks prior to screening visit 1
    b. dimethylfumarate, diroximel-fumarate within 4 weeks prior to screening visit 1
    c. teriflunomide within 4 weeks prior to screening visit 1, provided accelerated elimination procedure (eg. cholestyramine) was performed and teriflunomide plasma level are below 0.02 mg/L before randomization
    d. fingolimod, ozanimod within 12 weeks prior to screening visit 1, provided normal lymphocyte counts (see exclusion criterion No. 18)
    e. siponimod, ponesimod within 8 weeks prior to screening visit 1, provided normal lymphocyte counts (see exclusion criterion No. 18)
    f. natalizumab within 12 weeks prior to screening visit 1
    g. ocrelizumab, ofatumumab, rituximab, alemtuzumab, cladribine, mitoxantrone within 52 weeks prior to screening visit 1
    h. plasma exchange, intravenous immunoglobulin within 8 weeks prior to screening visit 1
    i. azathioprine, methotrexate, cyclophosphamide or any other continuous immunosuppressive therapy within 24 weeks prior to screening visit 1
    j. any other immunosuppressive monoclonal antibody treatment within 24 weeks prior to screening visit 1
    k. Prior autologous hematopoietic stem cell transplantation
    l. Corticosteroid treatment for MS relapse within 4 weeks prior to screening visit 1
    m. Patients who participated in the ETIMSred trial
    3. History of HIV, chronic or active Hepatitis C, chronic or active Hepatitis B or prior Syphilis, which has not been sufficiently treated
    4. Long-COVID19 Syndrome
    5. History of splenectomy or chronic liver disease
    6. History of coronary artery disease, chronic heart failure, aortic stenosis
    7. Current anticoagulation therapy
    8. Uncontrolled grade II hypertension (≥160 systolic and/or ≥100 diastolic blood pressure; according to ISH global practice guidelines) despite treatment or without treatment
    9. History of stroke
    10. Pregnant female confirmed by a positive pregnancy test or breast-feeding
    11. History of alcohol or drug abuse within the 1 year prior to screening visit 1
    12. History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ
    13. History of or existing relevant central nervous system disorder (other than MS)
    14. Allergy to gadolinium-based contrast agents
    15. Any other disease or condition, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures

    Specific exclusion criteria (to be assessed during the baseline period):
    16. Anemia, defined as hemoglobin levels ≤12.5 g/dl (7.25 mmol/l) for female and ≤13.5 g/dl (8.37 mmol/l) for male participants (may be repeated if 11.5 -12.5 g/dl in females and 12.5 - 13.5 g/dl in males)
    17. Erythrocyte count <4.0 E12/L in female and <4.5 E12/L in male patients (may be repeated if >3.8 E12/L in female and >4.3 E12/L in male)
    18. Lymphopenia with total lymphocyte counts ≤ 1000/µl (may be repeated if >800/µl)
    19. Positive HIV testing
    20. Positive results of baseline period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection
    21. Patient is not eligible for blood donation according to local regulation
    22. Having one or more of the following laboratory results:
    a. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (may be repeated if eGFR is 45-59 mL/min/1.73 m2)
    b. ALT or AST > 3 x upper limit of normal (ULN; may be repeated if 3.1-4 x ULN)
    c. Total bilirubin greater than 2 x ULN (may be repeated if 2.1 - 3 x ULN), with the exception for patients with Gilbert’s disease
    d. Platelet count ≤ 100E9/L (may be repeated if 80-100E9/L)
    e. Abnormalities in hepatic synthetic function tests (PT time, INR, PTT, albumin) as judged by the Investigator to be clinically significant
    E.5 End points
    E.5.1Primary end point(s)
    Safety (Part A and B)
    • Safety and tolerability of CLS12311 measured by the number and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) and/or worsening of disease by clinical (relapses) and imaging (number and size of brain lesions)

    Efficacy (Part B only)
    • The cumulative number of new brain lesions on the MRI scans developed in the treatment phase between weeks 16 and 24 compared to the pre-treatment number of new brain MRI lesions developed between weeks -8 and 0 for any dose.

    New lesions on brain MRI are defined as being:
    • Contrast enhancing lesions on the reference scan at weeks -8 and 16 or
    • new/enlarging T2 lesions on scan at:
    • week 0 compared to scan at week -8
    • week 24 compared to scan at week 16

    MRIs will be assessed centrally by independent readers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    E.5.2Secondary end point(s)
    Safety endpoints (Part A and B):
    • Number and severity of TEAEs and TESAEs in each dose group
    • Number of confirmed relapses in the treatment phase in each dose group
    • Changes in clinical measures of disease severity (EDSS, 9-HPT, T25FW, SDMT) following CLS12311 administration in each dose group (Part A only EDSS)

    Efficacy endpoints (Part B):
    • Number of new lesions on brain MRI (as defined above) in weeks 16-24 in the three dose groups
    • Efficacy of CLS12311 in reducing the number of new brain MRI lesions (as defined above) in defined subgroups, e.g. stratified for HLA or immunological parameters

    Exploratory immunological and biomarker measures (Part A and B):
    • Percentage of patients in each dose group showing a reduction of antigen-specific T cells against the protein(s) they responded to at study entry
    • Changes in predefined serum biomarkers of disease activity and in other markers related to tolerance induction
    • Mechanistic profiling of serum and blood cells will be performed by measuring specific biomarkers of tolerance, tissue damage and inflammation as well as broad-based methods including but not limited to multi-analyte measurements, transcriptomics and proteomics.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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
    Part A: open-label, ascending dose Part B: randomized, dose-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Switzerland
    Czechia
    Germany
    Italy
    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 years2
    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 years2
    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: 142
    F.1.3Elderly (>=65 years) No
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 142
    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, patients will be treated according to the local 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 Decision2023-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA