Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-97540 · 4 trials · 9 indications
The occurrence of DLT is the primary endpoint and will be assessed for all patients treated at the expansion dose.
This will be determined by the percentage of participants in treatment-free remission defined as a BVASv3 of 0 off immunosuppressive therapy.
For Cohorts 1 and 2
| Arm | Type | Description |
|---|---|---|
| Administration of CC-97540 | EXPERIMENTAL | - |
| CC-97540 | EXPERIMENTAL | Prior to receiving CC-97540, participants will undergo lymphodepleting chemotherapy. Lymphodepleting chemotherapy is the combination of cyclophosphamide and fludarabine and will be administered intravenously. CC-97540 will be infused intravenously on day 0 only. |
| Administration of CC-97540 (RMS arm) | EXPERIMENTAL | - |
| Administration of CC-97540 (PMS arm) | EXPERIMENTAL | - |
| Administration of CC-97540 (MG arm) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CC-97540 | DRUG | Specified dose on specified days |
| Fludarabine | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
| Lymphodepletion Chemotherapy | DRUG | Intravenous infusion of cyclophosphamide and fludarabine |
| Tocilizumab | DRUG | Specified dose on specified days |
Inclusion Criteria: * Participants must meet EULAR/ACR 2019 criteria for SLE. * Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. * Participants must have active disease when signing ICF. Exclusion...
CC-97540 is an investigational CD19-targeted CAR T cell therapy being studied for severe, refractory autoimmune diseases, including systemic lupus erythematosus, multiple sclerosis, antineutrophil cytoplasmic antibody-associated vasculitis, and other conditions like myasthenia gravis and rheumatoid arthritis.
CC-97540 is a CD19-targeted NEX-T CAR T cell therapy. It is designed to recognize and eliminate CD19-expressing B cells, which are implicated in the pathogenesis of autoimmune diseases, potentially resetting the immune system.
CC-97540 is being developed by Bristol-Myers Squibb Company (BMY). The company is conducting multiple clinical trials to evaluate the therapy in autoimmune indications.
CC-97540 is in Phase 1 and Phase 2 clinical trials. It is investigational and not yet approved. Studies are active in systemic lupus erythematosus, multiple sclerosis, and antineutrophil cytoplasmic antibody-associated vasculitis.
CC-97540 is being studied in several trials: NCT05869955 (Breakfree-1) in severe autoimmune diseases, NCT06220201 (Breakfree-2) in multiple sclerosis and myasthenia gravis, NCT07015983 (Breakfree-SLE) in systemic lupus erythematosus, and NCT07388277 in ANCA-associated vasculitis.
Yes, CC-97540 is also known as BMS-986353 or zola-cel. In the Breakfree-SLE trial, it is referred to as CC-97540 (BMS-986353 or zola-cel), indicating these names refer to the same investigational therapy.