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Using peptide-coupled red blood cells to treat multiple sclerosis

Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients with Relapsing Remitting Multiple Sclerosis - RED4MS Trial

Phase1; Phase2 Interventional Cellerys AG · NCT06430671

This study is testing a new treatment using specially modified red blood cells to see if it can help people with relapsing-remitting multiple sclerosis manage their symptoms better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment135 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorCellerys AG Industry-sponsored
Locations21 sites (Hradec Kralove and 20 other locations)
Trial IDNCT06430671 on ClinicalTrials.gov

What this trial studies

The RED4MS trial evaluates the safety, tolerability, and efficacy of autologous peptide-coupled red blood cells (CLS12311) in patients with relapsing-remitting multiple sclerosis (RRMS). It consists of two parts: Part A is an open-label, dose-escalation study involving 9 patients receiving varying doses of the therapy, while Part B is a randomized, dose-blinded study with 45 patients to assess the safety and efficacy of three different doses. Patients will receive two cycles of treatment, with the aim of inducing antigen-specific immune tolerance to manage their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 with a diagnosis of RRMS, experiencing active disease and meeting specific inclusion criteria.

Not a fit: Patients with a disease duration of 10 years or more, or those currently on approved therapies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel approach to inducing immune tolerance in patients with RRMS, potentially reducing disease activity.

How similar studies have performed: While the approach of using peptide-coupled red blood cells is innovative, similar studies have shown promise in other autoimmune conditions, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria (Part A and B):

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

Exclusion Criteria (Part A and B):

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 specified in the protocol
3. History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B or Syphilis
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 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 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.
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 regulations
22. Having one or more of the following laboratory results:

    1. Estimated glomerular filtration rate (eGFR)\< 60 mL/min/1.73 m2 (may be repeated if eGFR 45-59 mL/min/1.73 m2)
    2. ALT or AST \>3x upper limit of normal (ULN; may be repeated if 3.1-4x ULN)
    3. Total bilirubin greater than 2x ULN (may be repeated if 2.1-3x ULN), with the exception for patients with Gilbert's disease
    4. Platelet count ≤100x109/L (may be repeated if 80-100x 109/L)
    5. Abnormalities in hepatic synthetic function tests as judged by the Investigator to be clinically significant

Where this trial is running

Hradec Kralove and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing-remitting Multiple Sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.