Relapsing Remitting Multiple Sclerosis (RRMS)
Conditions
Brief summary
Safety endpoint: Safety and tolerability of CLS12311 measured by the number and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) and/or worsening of disease by clinical (relapses) and imaging (number and size of MRI brain lesions). MRIs will be assessed centrally by independent readers.
Detailed description
[Safety endpoints]: Number and severity of TEAEs and TESAEs in each dose group, [Safety endpoints]: Number of confirmed relapses in the treatment phase in each dose group, [Safety endpoints]: Changes in clinical measures of disease severity (EDSS, 9-HPT, T25- FW, SDMT) following CLS12311 administration in each dose group, [Exploratory immunological and biomarker measures]: Percentage of patients in each dose group showing a reduction of antigen-specific T cells against the protein(s) they responded to at the study entry, [Exploratory immunological and biomarker measures]: Changes in predefined serum- and cellular biomarkers including autoantigen-specific T cell responses that would indicate proinflammatory activation
Interventions
DRUGAutologous uncoupled red blood cells (RBCs)
Sponsors
Cellerys AG
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoint: Safety and tolerability of CLS12311 measured by the number and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) and/or worsening of disease by clinical (relapses) and imaging (number and size of MRI brain lesions). MRIs will be assessed centrally by independent readers. | — |
Secondary
| Measure | Time frame |
|---|---|
| [Safety endpoints]: Number and severity of TEAEs and TESAEs in each dose group, [Safety endpoints]: Number of confirmed relapses in the treatment phase in each dose group, [Safety endpoints]: Changes in clinical measures of disease severity (EDSS, 9-HPT, T25- FW, SDMT) following CLS12311 administration in each dose group, [Exploratory immunological and biomarker measures]: Percentage of patients in each dose group showing a reduction of antigen-specific T cells against the protein(s) they responded to at the study entry, [Exploratory immunological and biomarker measures]: Changes in predefined serum- and cellular biomarkers including autoantigen-specific T cell responses that would indicate proinflammatory activation | — |
Countries
Czechia, Germany, Italy
Outcome results
None listed