Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CABA-201 · 4 trials · 14 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
Incidence and severity of AEs
≥40 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement
≥20 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement
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 Phase 2b - Sub-study 1 | EXPERIMENTAL | Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with DM and ASyS. |
| CABA-201 Phase 2b - Sub-study 2 | EXPERIMENTAL | Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with IMNM. |
| 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 |
| CABA-201 following preconditioning with fludarabine and cyclophosphamide | 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...
CABA-201 is an investigational CD19-targeted CAR T cell therapy being developed by Cabaletta Bio, Inc. for autoimmune diseases. It is given following preconditioning with fludarabine and cyclophosphamide. Cabaletta is studying it in generalized myasthenia gravis, idiopathic inflammatory myopathy, systemic lupus erythematosus, and systemic sclerosis. It is in Phase 1 clinical development and has received Orphan Drug and Fast Track designations from the FDA.
CABA-201 is being studied for generalized myasthenia gravis, idiopathic inflammatory myopathy, systemic lupus erythematosus, and systemic sclerosis. These are autoimmune conditions in which the immune system attacks the body's own tissues. The trials are evaluating safety and efficacy in adults and, for some indications, children.
CABA-201 targets CD19, a protein found on the surface of B cells. By binding CD19, the therapy is designed to deplete B cells, which are thought to drive the autoimmune conditions being studied. CD19 is a protein target, and CABA-201 is a monoclonal antibody-based CAR T cell therapy.
CABA-201 is developed by Cabaletta Bio, Inc., which trades on the Nasdaq under the ticker CABA. The company is running the RESET clinical program for the therapy across several autoimmune indications.
CABA-201 is in Phase 1 clinical development and is investigational. It has not been approved by the FDA. The RESET-MG and RESET-SLE studies are Phase 1, while the RESET-SSc and RESET-Myositis studies are Phase 2. All four studies are currently recruiting participants.
CABA-201 is being evaluated in four recruiting trials: RESET-MG (NCT06359041) in generalized myasthenia gravis, RESET-Myositis (NCT06154252) in idiopathic inflammatory myopathy, RESET-SLE (NCT06121297) in systemic lupus erythematosus, and RESET-SSc (NCT06328777) in systemic sclerosis. These studies are enrolling participants in the United States and several other countries.