drugset / Trial / NCT05767359
CAR- PRISM (PRecision Intervention Smoldering Myeloma)
Phase 2
Active not recruiting
20 enrolled
Dana-Farber Cancer Institute
Janssen Research & Development, LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophosphamide (a lymphodepleting chemotherapy) * Fludarabine (a lymphodepleting chemotherapy)
Timeline
- Start
- 2023-04-19
- Primary completion
- 2025-12-15
- Completion
- 2040-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ciltacabtagene autoleucel | Cell therapy | 300000 cells/kg | Intravenous |
| Subject | ciltacabtagene autoleucel | Cell therapy | 500000 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |