4 active not recruiting, 2 not yet recruiting. 3 Phase 1, 3 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Active not recruiting 3 |
| Phase 2 | 3 | Active not recruiting 2, Not yet recruiting 1 |
| Phase 3 | 1 | Not yet recruiting 1 |
Follow BMS-986353: new trials by email Literature Review of BMS-986353 trials Research Report on BMS-986353
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis BMS-986353, Fludarabine, Cyclophosphamide - Systemic Sclerosis | Phase 3 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 92 | 2027-02-03 | 2026-09-18 |
| Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE) BMS-986353, Fludarabine Phosphate, Cyclophosphamide - Chronic Immune Thrombocytopenia, Autoimmune Hemolytic Anemia | Phase 2 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 52 | 2026-08-31 | 2026-07-09 |
| CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis CC-97540, Lymphodepletion Chemotherapy - Antineutrophil Cytoplasmic Antibody-associated Vasculitis | Phase 1 / Phase 2 | Active not recruiting | Marcela V. Maus, M.D.,Ph.D. | 12 | 2026-03-30 | 2026-09-10 |
| A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) CC-97540, Fludarabine, Cyclophosphamide - Lupus Erythematosus, Systemic, Lupus Nephritis | Phase 2 | Active not recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 89 | 2025-07-14 | 2026-08-03 |
| A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2) CC-97540, Fludarabine, Cyclophosphamide - Multiple Sclerosis, Myasthenia Gravis | Phase 1 | Active not recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 120 | 2024-03-28 | 2026-08-03 |
| A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1) CC-97540, Fludarabine, Cyclophosphamide - Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy | Phase 1 | Active not recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 270 | 2023-09-13 | 2026-08-03 |
Lupus Erythematosus, Systemic (2) · Scleroderma, Systemic (2) · Anemia, Hemolytic, Autoimmune (1) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (1) · Arthritis, Rheumatoid (1) · Lupus Nephritis (1) · Multiple Sclerosis (1) · Myasthenia Gravis (1) · Myositis (1)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (5) · Marcela V. Maus, M.D.,Ph.D. (1)
United States (6) · Germany (5) · Belgium (4) · France (4) · Spain (4) · United Kingdom (4) · Italy (3) · Canada (2) · Denmark (2) · Japan (2) · Argentina (1) · Austria (1) · Brazil (1) · Israel (1) · Poland (1)
2023 (2), 2025 (1)