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

NCT06430671 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MSB-IG-H-2101
• Study Type: interventional
• Target: 11
• Locations: 4 countries
• Sites: 8

Brief 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.

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311]

  Number and severity of adverse events (AEs) and serious adverse events (SAEs) and worsening of disease measured by clinical (relapses) and imaging (number \& size of brain MRI lesions)

  on average 48 weeks

Secondary Outcomes (6)

• Incidence of treatment-related adverse events as assessed by CTCAE v4.0 in each dose group [Safety of CLS12311]

  on average 48 weeks

• Incidence of patients experiencing worsening of MS in each dose group [Safety of CLS12311]

  on average 48 weeks

• Incidence of patients experiencing worsening of EDSS in each dose group [Safety of CLS12311]

  on average 48 weeks

• Incidence of patients experiencing worsening of T25-FW in each dose group [Safety of CLS12311]

  on average 48 weeks

• Incidence of patients experiencing worsening of 9-HPT in each dose group [Safety of CLS12311]

  on average 48 weeks

Study Arms (3)

CLS12311 low

EXPERIMENTAL

Low dose CLS12311

Drug: CLS12311 low; Drug: uncoupled RBCs

CLS12311 medium

EXPERIMENTAL

Medium dose CLS12311

Drug: CLS12311 medium; Drug: uncoupled RBCs

CLS12311 high

EXPERIMENTAL

High dose CLS12311

Drug: CLS12311 high

Interventions

CLS12311 low DRUG

Peptide-coupled Red Blood Cells (RBCs)

CLS12311 low

CLS12311 medium DRUG

Peptide-coupled Red Blood Cells (RBCs)

CLS12311 medium

CLS12311 high DRUG

Peptide-coupled Red Blood Cells (RBCs)

CLS12311 high

uncoupled RBCs DRUG

autologous Red Blood Cells (RBCs)

CLS12311 low; CLS12311 medium

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cellerys AG: lead
• Novartis: collaborator
• Scope International AG: collaborator
• Tetec AG: collaborator
• Jung Diagnostics GmbH: collaborator

Study Sites (8)

RS Centrum - Neurologická klinika

Prague, 12808, Czechia

Location

Neurologická klinika 2. LF UK a FN Motol

Prague, 15006, Czechia

Location

Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik für Neurologie

Hamburg, Hamburg, 20246, Germany

Location

Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP)

Göttingen, Lower Saxony, 37075, Germany

Location

Universitätsklinikum Münster (UKM), Klinik für Neurologie

Münster, North Rhine-Westphalia, 48149, Germany

Location

Azienda Ospedaliero Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Bellevue Medical Group (BMG), Neurozentrum

Zurich, Canton of Zurich, 8001, Switzerland

Location

UniversitätsSpital Zürich (USZ), Klinik für Neurologie

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 28, 2024
• Study Start: June 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); CZ (2); DE (3); IT (1)