Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CABA-201 · 3 trials · 6 indications
Incidence and severity of AEs
Mean change from baseline in % predicted FVC without any immunomodulatory or anti-fibrotic medications and on no or low dose of steroids
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.
| Arm | Type | Description |
|---|---|---|
| CABA-201 Phase 1/2 | EXPERIMENTAL | Severe Skin Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with severe skin involvement Organ Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with organ involvement |
| CABA-201 Phase 2b - Sub-study | EXPERIMENTAL | Infusion of CABA-201 with preconditioning in subjects with SSc |
| CABA-201 | EXPERIMENTAL | AChR Antibody-Positive Cohort or AChR Antibody-Negative Cohort |
| CABA-201, No Preconditioning | EXPERIMENTAL | Infusion of CABA-201 with no preconditioning in subjects with gMG |
| CABA-201 with FLU/CY Preconditioning | EXPERIMENTAL | LN 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 |
| Name | Type | Description |
|---|---|---|
| CABA-201 | BIOLOGICAL | Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide |
Inclusion Criteria: * Age ≥18 and ≤75 * A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria. * Early active disease * Evidence of significant skin, pulmonary, or cardiac involvement Exclusion Criteria: * Co...
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CABA-201 is an investigational CD19-targeted therapy being studied for systemic lupus erythematosus (SLE), systemic sclerosis, and generalized myasthenia gravis (gMG). It is a monoclonal antibody-based CAR T cell therapy in Phase 1 and Phase 2 clinical trials for these autoimmune conditions.
CABA-201 targets CD19, a protein found on B cells. By targeting CD19, the therapy is designed to deplete B cells involved in autoimmune disease. It is being evaluated in clinical trials for systemic lupus erythematosus, systemic sclerosis, and generalized myasthenia gravis.
CABA-201 is being developed by Cabaletta Bio, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CABA. The company is conducting clinical trials of CABA-201 in multiple autoimmune indications.
CABA-201 is in Phase 1 and Phase 2 clinical trials. It is an investigational therapy, not yet approved by the FDA. The drug has received Orphan Drug and Fast Track designations from the FDA for its studied indications.
CABA-201 is being studied in three open-label trials: NCT06121297 (RESET-SLE) for systemic lupus erythematosus, NCT06328777 (RESET-SSc) for systemic sclerosis, and NCT06359041 (RESET-MG) for generalized myasthenia gravis. All trials are recruiting participants in the United States, with the SLE trial also enrolling in Canada and Spain.
Yes, CABA-201 is a CD19-CAR T cell therapy. It is designed to target CD19 on B cells and is being investigated for autoimmune diseases including systemic lupus erythematosus, systemic sclerosis, and generalized myasthenia gravis.