drugset / Trial / NCT07335562
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
Phase 3
Recruiting
92 enrolled
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Celgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
Timeline
- Start
- 2026-08-29
- Primary completion
- 2028-11-14
- Completion
- 2030-11-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | — | — |
| Subject | Rituximab | Monoclonal antibody | — | — |
| Subject | Tocilizumab | Monoclonal antibody | — | — |
| Subject | Zolacabtagene- Autoleucel | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |