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
Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik für Neurologie
Hamburg, Hamburg, Germany
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)
Time frame: on average 48 weeks
Incidence of treatment-related adverse events as assessed by CTCAE v4.0 in each dose group [Safety of CLS12311]
Number and severity of treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) in each dose group
Time frame: on average 48 weeks
Incidence of patients experiencing worsening of MS in each dose group [Safety of CLS12311]
Number of confirmed relapses in the treatment phase in each dose group
Time frame: on average 48 weeks
Incidence of patients experiencing worsening of EDSS in each dose group [Safety of CLS12311]
Change in Expanded Disability Status Scale (EDSS) in each dose group
Time frame: on average 48 weeks
Incidence of patients experiencing worsening of T25-FW in each dose group [Safety of CLS12311]
Change in Timed 25-Foot Walk (T25-FW) in each dose group
Time frame: on average 48 weeks
Incidence of patients experiencing worsening of 9-HPT in each dose group [Safety of CLS12311]
Change in 9-Hole Peg Test (9-HPT) in each dose group
Time frame: on average 48 weeks
Incidence of patients experiencing worsening of SDMT in each dose group [Safety of CLS12311]
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autologous Red Blood Cells (RBCs)
Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP)
Göttingen, Lower Saxony, Germany
Universitätsklinikum Münster (UKM), Klinik für Neurologie
Münster, North Rhine-Westphalia, Germany
Azienda Ospedaliero Universitaria Careggi
Florence, Tuscany, Italy
Bellevue Medical Group (BMG), Neurozentrum
Zurich, Canton of Zurich, Switzerland
UniversitätsSpital Zürich (USZ), Klinik für Neurologie
Zurich, Canton of Zurich, Switzerland
Change in Symbol Digit Modalities Test (SDMT) in each dose group
Time frame: on average 48 weeks