Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
- Conditions
- Relapsing-remitting Multiple Sclerosis (RRMS)
- Interventions
- Drug: CLS12311 lowDrug: CLS12311 mediumDrug: CLS12311 highDrug: uncoupled RBCs
- Registration Number
- NCT06430671
- Lead Sponsor
- Cellerys AG
- Brief Summary
RED4MS is a clinical trial to assess the safety, tolerability and efficacy of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) chemically coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.
- Detailed Description
The RED4MS trial is designed as a combination of a phase Ib (part A) and a phase IIa (part B) study.
Part A is an open-label, dose-escalation 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.
Part B is a baseline-to-treatment, dose-blinded, randomized study and is designed to test the safety and efficacy of three different doses of CLS12311. During baseline phase, a total of 45 patients with active disease on magnetic resonance imaging (MRI) will be selected for the treatment phase and randomized in a 1:1:1 ratio into one of three dosing groups. Each patient will receive two cycles of therapy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CLS12311 low uncoupled RBCs Low dose CLS12311 CLS12311 low CLS12311 low Low dose CLS12311 CLS12311 medium CLS12311 medium Medium dose CLS12311 CLS12311 medium uncoupled RBCs Medium dose CLS12311 CLS12311 high CLS12311 high High dose CLS12311
- Primary Outcome Measures
Name Time Method Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311] on average 48 weeks 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)
Overall reduction in the number of new brain lesions in treatment phase vs. pre-treatment phase [Efficacy of CLS12311] completion of treatment phase, on average 24 weeks The cumulative number of new brain lesions on the MRI scans developed in the post-treatment phase during weeks 16-24 compared to pre-treatment number of new brain lesions developed during weeks -8 and 0 for any dose
- Secondary Outcome Measures
Name Time Method Incidence of treatment-related adverse events as assessed by CTCAE v4.0 in each dose group [Safety of CLS12311] on average 48 weeks Number and severity of treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) in each dose group
Incidence of patients experiencing worsening of MS in each dose group [Safety of CLS12311] on average 48 weeks Number of confirmed relapses in the treatment phase in each dose group
Incidence of patients experiencing worsening of EDSS in each dose group [Safety of CLS12311] on average 48 weeks Change in Expanded Disability Status Scale (EDSS) in each dose group
Incidence of patients experiencing worsening of T25-FW in each dose group [Safety of CLS12311] on average 48 weeks Change in Timed 25-Foot Walk (T25-FW) in each dose group
Efficacy of CLS12311 in reducing number of new brain lesions as a surogate for inflammatory disease activity completion of treatment phase, on average 24 weeks Number of new lesions on brain MRI in weeks 16-24 in each dose group
Efficacy of CLS12311 in reducing the number of new brain lesions in defined subgroups completion of treatment phase, on average 24 weeks Number of new brain lesions in defined subgroups, stratified for HLA or immunological parameters through the treatment phase
Incidence of patients experiencing worsening of 9-HPT in each dose group [Safety of CLS12311] on average 48 weeks Change in 9-Hole Peg Test (9-HPT) in each dose group
Incidence of patients experiencing worsening of SDMT in each dose group [Safety of CLS12311] on average 48 weeks Change in Symbol Digit Modalities Test (SDMT) in each dose group
Trial Locations
- Locations (20)
Neurologická klinika 2. LF UK a FN Motol
🇨🇿Praha 5, Czech Republic
RS Centrum - Neurologická klinika
🇨🇿Praha, Czech Republic
Fakultni Nemocnice Kralovske Vinohrady, Neurologická Klinika
🇨🇿Prague, Czech Republic
Fakultni Nemocnice Hradec Kralove, Neurologická Klinika
🇨🇿Hradec Kralove, Czech Republic
Universitätsklinikum Mannheim, Klinik für Neurologie
🇩🇪Mannheim, Baden-Württemberg, Germany
Universitätsklinikum Ulm, Klinik für Neurologie
🇩🇪Ulm, Baden-Württemberg, Germany
Klinikum rechts der Isar Technische Universität München, Klinik für Neurologie
🇩🇪München, Bayern, Germany
Fraunhofer Institut fĂĽr Translationale Medizin und Pharmakologie (ITMP)
🇩🇪Göttingen, Niedersachsen, Germany
Universitätsklinikum Münster (UKM), Klinik für Neurologie
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitätsklinikum Carl Gustav Carus, Klinik für Neurologie
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
🇩🇪Leipzig, Sachsen, Germany
Charite Universitaetsmedizin Berlin KöR, Studienambulanz Klinische Neuroimmunologie am Standort NCRC
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), Klinik für Neurologie
🇩🇪Hamburg, Germany
Azienda Ospedaliero Universitaria Careggi
🇮🇹Florence, Tuscany, Italy
IRCCS Ospedale Policlinico San Martino, Clinica Neurologica
🇮🇹Genoa, Italy
Azienda Ospedaliera di Padova, Clinica Neurologica
🇮🇹Padova, Italy
San Camillo Forlanini Hospital, Day Hospital Neurologico
🇮🇹Rome, Italy
Inselspital, Universitätsspital Bern, Universitäres Neurozentrum Bern
🇨đź‡Bern, Switzerland
Bellevue Medical Group (BMG), Neurozentrum
🇨đź‡ZĂĽrich, Switzerland
UniversitätsSpital Zürich (USZ), Klinik für Neurologie
🇨đź‡ZĂĽrich, Switzerland