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BMS-986353
BMS-986353 is a CAR-T cell therapy that redirects patient T cells to recognize and eliminate cancer cells expressing a specific tumor antigen.
BMS-986353 is a CAR-T cell therapy that redirects patient T cells to recognize and eliminate cancer cells expressing a specific tumor antigen. Used for Hematologic malignancies (specific indication in Phase 3 development).
At a glance
| Generic name | BMS-986353 |
|---|---|
| Also known as | CC-97540 |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
| Drug class | CAR-T cell therapy |
| Target | Tumor-associated antigen (specific target not publicly disclosed in detail) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BMS-986353 is an autologous CAR-T cell therapy developed by Juno Therapeutics. It involves engineering a patient's own T cells to express a chimeric antigen receptor (CAR) that targets a defined tumor-associated antigen, enabling the modified T cells to recognize, proliferate, and destroy cancer cells. This approach harnesses the patient's immune system for targeted cancer cell elimination.
Approved indications
- Hematologic malignancies (specific indication in Phase 3 development)
Common side effects
- Cytokine release syndrome
- Immune effector cell-associated neurotoxicity syndrome (ICANS)
- Cytopenias
- Infections
Key clinical trials
- 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) (PHASE2)
- A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacaptagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (PHASE3)
- 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) (PHASE1)
- CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis (PHASE1, PHASE2)
- A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BMS-986353 CI brief — competitive landscape report
- BMS-986353 updates RSS · CI watch RSS
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company portfolio CI