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BMS-986515 · 1 trial · 1 indication
All participants
All participants
All participants
All participants
All participants
All participants
| Arm | Type | Description |
|---|---|---|
| BMS-986515 Administration | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986515 | GENETIC | Specified dose on specified days |
| Fludarabine | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
| Tocilizumab | DRUG | Specified dose on specified days |
Inclusion Criteria \- Systemic lupus erythematosus (SLE) population:. i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR). ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear a...
BMS-986515 is an investigational gene therapy being developed for severe, refractory autoimmune diseases. It is a CD19-targeted allogeneic CAR T cell therapy made from healthy donor cells. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BMS-986515 targets CD19, a protein found on the surface of B cells. By targeting CD19, the allogeneic CAR T cell therapy is designed to eliminate B cells involved in autoimmune disease. The therapy uses healthy donor cells rather than a patient's own cells.
BMS-986515 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting a Phase 1 clinical trial of the therapy in patients with severe, refractory autoimmune diseases.
BMS-986515 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is currently recruiting participants with severe, refractory autoimmune diseases.
BMS-986515 is being studied in a single Phase 1 clinical trial registered as NCT07115745. This open-label, uncontrolled study is recruiting 125 participants aged 18 years and older with severe, refractory autoimmune diseases. The trial is enrolling in the United States, Australia, Brazil, Czechia, France, Germany, Israel, Poland, Romania, and Spain.