drugset / Trial / NCT07709715
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Timeline
- Start
- 2027-01
- Primary completion
- 2028-12
- Completion
- 2032-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bortezomib | Small molecule | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Daratumumab | Monoclonal antibody | — | — |
| Comparator | Dexamethasone | Small molecule | — | — |
| Subject | NXC-201 | Cell therapy | — | — |