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CABA-201

Phase 1

Relapsing Multiple Sclerosis (RMS) | Monoclonal antibody | Immunology |Cabaletta Bio, Inc.|Last Updated: Oct 31, 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 Enrollment12
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07006805RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple SclerosisPHASE1 NOT YET_RECRUITING 12Jun 1, 2026Oct 1, 2029Oct 31, 2025 -
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Study Endpoints
Primary Endpoints
Primary (Part A: Dose Escalation) incidence and severity of adverse events
Up to 28 days after CABA-201 infusion

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.

Primary (Part B: Dose Expansion) incidence of and severity of adverse events in order to confirm the dose(s) of CABA-201
Up to 28 days after CABA-201 infusion

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.

Secondary Endpoints
Part A and Part B: To evaluate the incidence and severity of adverse events
Up to 156 weeks after CABA-201 infusion
Part A and Part B: To characterize the pharmacodynamics (PD)
Up to 156 weeks after CABA-201 infusion
Part A and Part B: To characterize the pharmacokinetics (PK)
Up to 156 weeks after CABA-201 infusion
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Relapsing MS CohortEXPERIMENTAL -
Progressive MS CohortEXPERIMENTAL -
Interventions
NameTypeDescription
CABA-201BIOLOGICALSingle intravenous infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria The main inclusion criteria include the following: * Able to provide informed consent. * Age ≥18 and ≤60 years of age. * Diagnosis of MS per the revised 2017 McDonald criteria (Thompson et al, 2018). * For participants with relapsing forms of MS only (RMS Cohort): 1. Moderate...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07006805primaryCompletionDate: changed
LOWMay 24, 2026NCT07006805studyFirstPostDate: changed