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Relapsing-remitting Multiple Sclerosis (RRMS)Phase 1RED4MSNCT06430671

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

A Phase 1 study testing CLS12311 low, CLS12311 medium and CLS12311 high in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Cellerys AG at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
CLS12311 low, CLS12311 medium and CLS12311 high
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
8 sitesin 4 countries
Study dates
18 Jun 2024to 23 Dec 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • RRMS according to the 2017 McDonald criteria
  • Male or female patients (assigned at birth) aged 18-55 years inclusive
  • Disease duration (since diagnosis) <10 years
  • Expanded Disability Status Scale (EDSS) at baseline 0-5.5
  • 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
  • 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
  • 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

Who cannot join

  • 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)
  • Prior treatment with any of the medications specified in the protocol
  • History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B or Syphilis
  • Long-Covid19 syndrome
  • History of splenectomy or chronic liver disease
  • History of coronary artery disease, chronic heart failure, aortic stenosis
Show all 27Show fewer
  • Current anticoagulation therapy
  • 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
  • History of stroke
  • Pregnant female confirmed by a positive pregnancy test or breast-feeding
  • History of alcohol or drug abuse within the 1 year prior to screening visit 1
  • History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ
  • History of or existing relevant central nervous system disorder (other than MS)
  • Allergy to gadolinium-based contrast agents
  • 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.
  • 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)
  • 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)
  • Lymphopenia with total lymphocyte counts ≤1000/µl (may be repeated if >800/µl)
  • Positive HIV testing
  • Positive results of baseline period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection
  • Patient is not eligible for blood donation according to local regulations
  • Having one or more of the following laboratory results:
  • Estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73 m2 (may be repeated if eGFR 45-59 mL/min/1.73 m2)
  • ALT or AST >3x upper limit of normal (ULN; may be repeated if 3.1-4x ULN)
  • Total bilirubin greater than 2x ULN (may be repeated if 2.1-3x ULN), with the exception for patients with Gilbert's disease
  • Platelet count ≤100x109/L (may be repeated if 80-100x 109/L)
  • Abnormalities in hepatic synthetic function tests as judged by the Investigator to be clinically significant

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Germany3 sites

  • Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP)

    Göttingen, Lower Saxony, 37075

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

    Hamburg, 20246

  • Universitätsklinikum Münster (UKM), Klinik für Neurologie

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Czechia2 sites

  • RS Centrum - Neurologická klinika

    Prague, 12808

  • Neurologická klinika 2. LF UK a FN Motol

    Prague, 15006

Other trials in Czechia

Switzerland2 sites

  • Bellevue Medical Group (BMG), Neurozentrum

    Zurich, 8001

  • UniversitätsSpital Zürich (USZ), Klinik für Neurologie

    Zurich, 8091

Other trials in Switzerland

Italy1 site

  • Azienda Ospedaliero Universitaria Careggi

    Florence, Tuscany, 50134

Other trials in Italy

About this study

Official title: 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

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.

Read the detailed 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.

Being tested
CLS12311 low, CLS12311 medium, CLS12311 high, uncoupled RBCs
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLS12311 lowDrug

    Peptide-coupled Red Blood Cells (RBCs)

  • CLS12311 mediumDrug

    Peptide-coupled Red Blood Cells (RBCs)

  • CLS12311 highDrug

    Peptide-coupled Red Blood Cells (RBCs)

  • uncoupled RBCsDrug

    autologous Red Blood Cells (RBCs)

Study groups in NCT06430671
Study groupRoleWhat they receive
CLS12311 lowExperimentalLow dose CLS12311
Receives: Drug: CLS12311 low; Drug: uncoupled RBCs
CLS12311 mediumExperimentalMedium dose CLS12311
Receives: Drug: CLS12311 medium; Drug: uncoupled RBCs
CLS12311 highExperimentalHigh dose CLS12311
Receives: Drug: CLS12311 high

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety of CLS12311]

    Number of treatment-emergent adverse events (TEAEs) during the treatment and safety follow-up period. TEAEs were defined as adverse events with first onset or worsening after the first blood donation for CLS12311 production and were graded according to CTCAE v4.0.

    Measured: From first blood donation for CLS12311 production through Week 48 (end of study)

Secondary outcomes (7)

  1. Incidence of Treatment-Related TEAEs in Each Dose Group [Safety of CLS12311]

    Number of treatment-related treatment-emergent adverse events (TEAEs) during the treatment and safety follow-up period. TEAEs were defined as adverse events with first onset or worsening after the first blood donation for CLS12311 production, considered related to study treatment or blood donation, and graded according to CTCAE v4.0.

    Measured: From first blood donation for CLS12311 production through Week 48 (end of study)

  2. Number of Patients With Confirmed MS Relapse in Each Dose Group [Safety of CLS12311]

    Number of patients with a centrally confirmed multiple sclerosis relapse in each dose group during the study period. Relapse was assessed according to protocol criteria as new or worsening neurological symptoms lasting at least 24 hours in the absence of fever or infection and confirmed by central neurological review.

    Measured: From baseline through Week 48 (end of study)

  3. Change in Number of New or Enlarging T2 Lesions on Brain MRI in Each Dose Group [Safety of CLS12311]

    Change from baseline to Week 48 in the number of contrast-enhancing lesions (CEL) and new or enlarging T2 lesions on brain MRI in each dose group.

    Measured: Baseline to Week 48 (end of study)

  4. Change in EDSS Score in Each Dose Group [Safety of CLS12311]

    Change from baseline to Week 48 in Expanded Disability Status Scale (EDSS) score in each dose group. The EDSS ranges from 0 to 10, with higher scores indicating greater disability. Negative values indicate improvement and positive values indicate worsening disability.

    Measured: Baseline to Week 48 (end of study)

  5. Change in T25-FW Performance in Each Dose Group [Safety of CLS12311]

    Percent change from baseline to Week 48 in Timed 25-Foot Walk (T25-FW) performance in each dose group. Negative values indicate improvement (faster walking time).

    Measured: Baseline to Week 48 (end of study)

  6. Change in 9HPT Performance in Each Dose Group [Safety of CLS12311]

    Percent change from baseline to Week 48 in 9-Hole Peg Test (9-HPT) performance in each dose group. Negative values indicate improvement (shorter completion time).

    Measured: Baseline to Week 48 (end of study)

  7. Change in SDMT Performance in Each Dose Group [Safety of CLS12311]

    Change from baseline to Week 48 in Symbol Digit Modalities Test (SDMT) score. The SDMT is a cognitive processing speed test with scores ranging from 0 to approximately 110 points. Higher scores indicate better cognitive performance.

    Measured: Baseline to Week 48 (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start18 Jun 2024
  3. Primary completion23 Dec 2025
  4. Study completion23 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Individual patients will be assigned to three dose groups. Patients will be allocated in the low, medium, high dose group according to the order of recruitment.
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06430671
Sponsor's protocol ID
MSB-IG-H-2101
Acronym
RED4MS
Status last verified
May 2026
First submitted
6 May 2024
Last updated
8 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CLS12311 low, CLS12311 medium and CLS12311 high in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Cellerys AG at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Czechia, Switzerland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety of CLS12311] (time frame: From first blood donation for CLS12311 production through Week 48 (end of study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06430671.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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