Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis

Last updated: July 1, 2025
Sponsor: Cellerys AG
Overall Status: Active - Not Recruiting

Phase

1

Condition

Memory Loss

Multiple Sclerosis

Neurologic Disorders

Treatment

CLS12311 low

CLS12311 medium

CLS12311 high

Clinical Study ID

NCT06430671
MSB-IG-H-2101
  • Ages 18-55
  • All Genders

Study Summary

RED4MS is a clinical trial to assess the safety and tolerability of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. RRMS according to the 2017 McDonald criteria

  2. Male or female patients (assigned at birth) aged 18-55 years inclusive

  3. Disease duration (since diagnosis) <10 years

  4. Expanded Disability Status Scale (EDSS) at baseline 0-5.5

  5. Untreated patients or patients being off therapy for the time-periods listed underexclusion criterion No. 2. Patients are either not eligible to receive approvedtherapies or have explicitly chosen not to receive such therapies after beingadequately informed by the investigators

  6. Only for female patients of childbearing potential (sexually mature, pre-menopausaland not surgically sterile): the patient is willing to use a highly effective methodof contraception throughout the treatment phase or at least for 4 weeks after thelast dose of the study drug

  7. Male patients willing to use contraception (such as a condoms) throughout thetreatment phase or at least for 4 weeks after the last dose of the study drug,unless surgically steril

Exclusion

Exclusion Criteria:

  1. Patients with an active chronic disease (or stable but treated withimmunomodulatory/-suppressive therapy) of the immune system other than MS (e.g.rheumatoid arthritis, scleroderma, Crohn's disease, ulcerative colitis, etc.) orwith a known immunodeficiency syndrome (AIDS, hereditary immune deficiency,drug-induced immune deficiency)

  2. Prior treatment with any of the medications specified in the protocol

  3. History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B orSyphilis

  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 bloodpressure according to the International Society of Hypertension (ISH) 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 excepthistory 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 thestudy according to the study protocol, or with the ability of the patients tocooperate and comply with the study procedures.

  16. Anemia, defined as hemoglobin levels ≤12.5 g/dl (7.25 mmol/l) for female and ≤13.5g/dl (8.37 mmol/l) for male participants (may be repeated if 11.5-12.5 g/dl infemales 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 berepeated 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 regulations

  22. Having one or more of the following laboratory results:

  23. Estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73 m2 (may be repeatedif eGFR 45-59 mL/min/1.73 m2)

  24. ALT or AST >3x upper limit of normal (ULN; may be repeated if 3.1-4x ULN)

  25. Total bilirubin greater than 2x ULN (may be repeated if 2.1-3x ULN), with theexception for patients with Gilbert's disease

  26. Platelet count ≤100x109/L (may be repeated if 80-100x 109/L)

  27. Abnormalities in hepatic synthetic function tests as judged by the Investigatorto be clinically significant

Study Design

Total Participants: 11
Treatment Group(s): 4
Primary Treatment: CLS12311 low
Phase: 1
Study Start date:
June 18, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The RED4MS trial is designed as an open-label, dose-escalation phase Ib study, enrolling 9 RRMS patients in three ascending dose groups. The first patient (sentinel) in each dose group will receive one cycle of the therapy, while the remaining patients will receive two treatment cycles.

Connect with a study center

  • Fakultni Nemocnice Hradec Kralove, Neurologická Klinika

    Hradec Kralove, 50003
    Czech Republic

    Site Not Available

  • Fakultni Nemocnice Kralovske Vinohrady, Neurologická Klinika

    Prague, 10000
    Czech Republic

    Site Not Available

  • RS Centrum - Neurologická klinika

    Praha, 12808
    Czech Republic

    Active - Recruiting

  • Neurologická klinika 2. LF UK a FN Motol

    Praha 5, 15006
    Czech Republic

    Active - Recruiting

  • RS Centrum - Neurologická klinika

    Praha, 12808
    Czechia

    Site Not Available

  • Neurologická klinika 2. LF UK a FN Motol

    Praha 5, 15006
    Czechia

    Site Not Available

  • Universitätsklinikum Mannheim, Klinik für Neurologie

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Universitätsklinikum Ulm, Klinik für Neurologie

    Ulm, Baden-Württemberg 89081
    Germany

    Site Not Available

  • Klinikum rechts der Isar Technische Universität München, Klinik für Neurologie

    München, Bayern 81675
    Germany

    Site Not Available

  • Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP)

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Fraunhofer Institut fürTranslationale Medizin und Pharmakologie (ITMP)

    Göttingen, Niedersachsen 37075
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster (UKM), Klinik für Neurologie

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus, Klinik für Neurologie

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin KöR, Studienambulanz Klinische Neuroimmunologie am Standort NCRC

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik für Neurologie

    Hamburg, 20246
    Germany

    Site Not Available

  • Azienda Ospedaliero Universitaria Careggi

    Florence, Tuscany 50134
    Italy

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino, Clinica Neurologica

    Genoa, 16132
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova, Clinica Neurologica

    Padova, 35128
    Italy

    Site Not Available

  • San Camillo Forlanini Hospital, Day Hospital Neurologico

    Rome, 00189
    Italy

    Site Not Available

  • Inselspital, Universitätsspital Bern, Universitäres Neurozentrum Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Bellevue Medical Group (BMG), Neurozentrum

    Zürich, 8001
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich (USZ), Klinik für Neurologie

    Zürich, 8091
    Switzerland

    Site Not Available

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