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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Peptide-coupled Red Blood Cells (RBCs)
Peptide-coupled Red Blood Cells (RBCs)
Peptide-coupled Red Blood Cells (RBCs)
RS Centrum - Neurologická klinika
Prague, Czechia
Neurologická klinika 2. LF UK a FN Motol
Prague, Czechia
Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP)
Göttingen, Lower Saxony, Germany
Universitätsklinikum Münster (UKM), Klinik für Neurologie
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.
Time frame: From first blood donation for CLS12311 production through Week 48 (end of study)
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.
Time frame: From first blood donation for CLS12311 production through Week 48 (end of study)
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.
Time frame: From baseline through Week 48 (end of study)
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.
Time frame: Baseline to Week 48 (end of study)
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.
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autologous Red Blood Cells (RBCs)
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik für Neurologie
Hamburg, Germany
Azienda Ospedaliero Universitaria Careggi
Florence, Tuscany, Italy
Bellevue Medical Group (BMG), Neurozentrum
Zurich, Switzerland
UniversitätsSpital Zürich (USZ), Klinik für Neurologie
Zurich, Switzerland
Time frame: Baseline to Week 48 (end of study)
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).
Time frame: Baseline to Week 48 (end of study)
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).
Time frame: Baseline to Week 48 (end of study)
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.
Time frame: Baseline to Week 48 (end of study)