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CABA-201

Phase 1

Systemic Lupus Erythematosus | Monoclonal antibody | Immunology |Cabaletta Bio, Inc.|Last Updated: Jul 22, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment28
FDA Designations
ORPHAN_DRUGFAST_TRACK
Clinical trial landscape

CABA-201 · 3 trials · 5 indications

Phase 1 3
NCT06359041RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia GravisGeneralized Myasthenia Gravis (gMG)
ACTIVE NOT_RECRUITING12 Analytics
NCT06328777RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic SclerosisSystemic Sclerosis
RECRUITING12 Analytics
NCT06121297RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus
RECRUITING28 Analytics
PHASE1ACTIVE NOT_RECRUITING
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG)Unlock trial analytics
PHASE1RECRUITING
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
Systemic SclerosisUnlock trial analytics
PHASE1RECRUITING
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Systemic Lupus ErythematosusUnlock trial analytics
Study Endpoints
Primary Endpoints
To evaluate incidence and severity of adverse events (AEs)
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.

To evaluate incidence of adverse events
Up to 28 days after CABA-201 infusion

Incidence and severity of AEs

Secondary Endpoints
To evaluate the incidence and severity of adverse events (AEs)
Up to 156 weeks
To characterize the pharmacodynamics (PD)
Up to 156 weeks
To characterize the pharmacokinetics (PK)
Up to 156 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CABA-201EXPERIMENTALAChR Antibody-Positive Cohort AChR Antibody-Negative Cohort
CABA-201 with FLU/CY PreconditioningEXPERIMENTALLN Cohort: Infusion of CABA-201 with preconditioning in subjects with LN Non-renal SLE Cohort: Infusion of CABA-201 with preconditioning in subjects with non-renal SLE who do not meet criteria for inclusion in the LN cohort Expansion Cohort: Infusion of CABA-201 with preconditioning in subjects with LN and SLE
CABA-201, No PreconditioningEXPERIMENTALInfusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE
Interventions
NameTypeDescription
CABA-201BIOLOGICALSingle intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Age ≥18 and ≤70 years of age * Diagnosis of MG with generalized muscle weakness meeting criteria as defined by the MGFA class II, III , IVa, and IVb. * Diagnosis of seropositive (autoantibodies AChR, MuSK and/or LRP4) or seronegative MG Exclusion Criteria: * Contraindication...

Countries:United StatesCanadaSpain
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Recent Changes (Last 90 Days)
LOWJul 22, 2026NCT06328777lastUpdatePostDate: changed
LOWJul 22, 2026NCT06328777lastUpdatePostDate: changed
LOWMay 26, 2026NCT06121297primaryCompletionDate: changed
LOWMay 26, 2026NCT06328777primaryCompletionDate: changed
LOWMay 26, 2026NCT06359041primaryCompletionDate: changed
LOWMay 24, 2026NCT06121297studyFirstPostDate: changed
LOWMay 24, 2026NCT06328777studyFirstPostDate: changed
LOWMay 24, 2026NCT06359041studyFirstPostDate: changed