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BMS-986353 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Arm A: BMS-986353 | EXPERIMENTAL | - |
| Arm B: Standard of Care | EXPERIMENTAL | - |
| Cohort 1 Part A ITP | EXPERIMENTAL | - |
| Cohort 1 Part A AIHA | EXPERIMENTAL | - |
| Cohort 1 Part B | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986353 | DRUG | 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 |
| Rituximab | DRUG | Specified dose on specified days |
| Nintedanib | DRUG | Specified dose on specified days |
| Fludarabine Phosphate | DRUG | Specified dose of specified days |
Inclusion Criteria \- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:. i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern a...
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BMS-986353, also known as Zolacabtagene-Autoleucel or Zola-cel, is an investigational CD19-CAR T cell therapy being studied for chronic immune thrombocytopenia and systemic sclerosis. It is a monoclonal antibody-based cell therapy in Phase 2 development for these autoimmune conditions.
BMS-986353 targets CD19, a protein found on B cells. As a CD19-CAR T cell therapy, it is designed to recognize and eliminate CD19-expressing cells, which are implicated in autoimmune diseases like systemic sclerosis and chronic immune thrombocytopenia.
BMS-986353 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the therapy's safety and efficacy in autoimmune conditions.
BMS-986353 is in Phase 2 clinical development. It is an investigational therapy, not yet approved by regulatory authorities. Two trials are planned: a Phase 3 study in systemic sclerosis and a Phase 2 study in autoimmune cytopenia, both not yet recruiting.
BMS-986353 is involved in two planned trials. NCT07335562 is a Phase 3 study comparing it to standard of care in active systemic sclerosis with 92 participants. NCT07603557 is a Phase 2 study in autoimmune cytopenia, including chronic immune thrombocytopenia, with 52 participants.
Yes, BMS-986353 is also known as Zolacabtagene-Autoleucel, or Zola-cel for short. These names refer to the same investigational CD19-CAR T cell therapy being developed by Bristol-Myers Squibb for autoimmune diseases.