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CLS12311 low

Phase 1

Relapsing-remitting Multiple Sclerosis (RRMS) | Small molecule | Immunology |Novartis AG|Last Updated: Jul 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06430671Peptide-coupled Red Blood Cells for the Treatment of Multiple SclerosisPHASE1 ACTIVE NOT_RECRUITING 11 — — Jun 18, 2024Dec 1, 2025Jul 3, 20258 Czechia, Germany +2
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Study Endpoints
Primary Endpoints
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)

Secondary Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CLS12311 lowEXPERIMENTALLow dose CLS12311
CLS12311 mediumEXPERIMENTALMedium dose CLS12311
CLS12311 highEXPERIMENTALHigh dose CLS12311
Interventions
NameTypeDescription
CLS12311 lowDRUGPeptide-coupled Red Blood Cells (RBCs)
CLS12311 mediumDRUGPeptide-coupled Red Blood Cells (RBCs)
CLS12311 highDRUGPeptide-coupled Red Blood Cells (RBCs)
uncoupled RBCsDRUGautologous Red Blood Cells (RBCs)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. RRMS according to the 2017 McDonald criteria 2. Male or female patients (assigned at birth) aged 18-55 years inclusive 3. Disease duration (since diagnosis) \<10 years 4. Expanded Disability Status Scale (EDSS) at baseline 0-5.5 5. Untreated patients or patients being off the...

Countries:CzechiaGermanyItalySwitzerland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06430671primaryCompletionDate: changed
LOWMay 24, 2026NCT06430671studyFirstPostDate: changed