Recent Updates
Recently added Catalysts

MuSK-CAART

Phase 1

MuSK Myasthenia Gravis | Monoclonal antibody | Neurology |Cabaletta Bio, Inc.|Last Updated: Nov 10, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05451212Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myasthenia GravisPHASE1 COMPLETED 7Nov 23, 2022Jul 24, 2025Nov 10, 20255 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Adverse events
3 months

Incidence of adverse events (AEs), including dose-limiting toxicities (DLTs) and AEs that are related to MuSK-CAART.

Secondary Endpoints
Total MuSK-CAART positive cells
Baseline
Percent of CAAR-transduced cells
Baseline
Cellular kinetics profile of MuSK-CAART
Up to 36 months
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MuSK-CAARTEXPERIMENTALCohort A: Infusion of MuSK-CAART at various dose levels with or without pre-treatment (6 groups planned). Cohort B: Infusion of MuSK-CAART at the dose regimen selected from Part A.
Interventions
NameTypeDescription
MuSK-CAARTBIOLOGICALIntravenous infusion of MuSK-CAART at different doses. Subjects may also receive MuSK-CAART following pre-treatment with CY, or CY plus FLU.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Confirmed diagnosis of MuSK-type MG with at least 1 prior positive anti-MuSK antibody test. * History of a negative anti-AChR (acetylcholine receptor) antibody test. * Positive anti-MuSK antibody test at screening * MG severity Class I to IVa on the MGFA (Myasthenia Gravis Fou...

Countries:United States
Unlock Eligibility Criteria