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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 by Bristol-Myers Squibb for severe, refractory autoimmune diseases. It is in Phase 1 clinical development and is designed as an allogeneic cell-based treatment. It has not been approved by any regulatory agency and remains under study.
BMS-986515 is being studied for severe, refractory autoimmune diseases, meaning autoimmune conditions that have not responded adequately to prior treatment. The Phase 1 trial enrolls adults aged 18 years and older with these refractory autoimmune diseases across sites in the United States, Australia, Brazil, Czechia, France, Germany, Israel, Poland, Romania and Spain.
Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of BMS-986515. The company sponsors the ongoing Phase 1 study of the therapy in participants with severe, refractory autoimmune diseases.
BMS-986515 is in Phase 1 clinical development. It is an investigational therapy and is not FDA approved. One Phase 1 trial is currently recruiting, and no trials of BMS-986515 have been completed.
BMS-986515 is being evaluated in the Phase 1 trial NCT07115745, titled A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases. The trial is recruiting and plans to enroll 125 participants aged 18 years and older, with enrollment open to all sexes.
Yes. BMS-986515 is being studied as an allogeneic CAR T cell therapy derived from healthy donors and directed at CD19. The Phase 1 trial NCT07115745 evaluates these CD19-targeted allogeneic CAR T cells in participants with severe, refractory autoimmune diseases. It is an investigational gene therapy that has not been approved.