Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rese-cel, Resecabtagene autoleucel
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 designed to be given after preconditioning with fludarabine and cyclophosphamide. It is in clinical development and has not been approved by 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. All of these uses are investigational and are being evaluated in clinical trials.
CABA-201 targets CD19, a protein found on the surface of B cells. By targeting CD19, the therapy is designed to deplete B cells. CD19 is a protein target, and the drug is a monoclonal antibody-based CAR T cell therapy.
CABA-201 is developed by Cabaletta Bio, Inc., which trades under the ticker CABA. The company is the sponsor of the clinical trials evaluating the therapy in autoimmune indications.
CABA-201 is in Phase 1 and Phase 2 clinical development. It is investigational and has not been approved by the FDA. The trials are currently recruiting participants.
CABA-201 is being evaluated in several recruiting trials: RESET-MG (NCT06359041) in generalized myasthenia gravis, RESET-SSc (NCT06328777) in systemic sclerosis, RESET-Myositis (NCT06154252) in idiopathic inflammatory myopathy, and RESET-SLE (NCT06121297) in systemic lupus erythematosus.