drugset / Trial / NCT04304144
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
Non-randomizedSequentialOpen-labelTreatment
Summary
AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab .
Timeline
- Start
- 2020-03-18
- Primary completion
- 2023-11-14
- Completion
- 2023-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anselamimab | Protein / enzyme biologic | 500 mg/m2 | Intravenous |
| Subject | Anselamimab | Protein / enzyme biologic | 750 mg/m2 | Intravenous |
| Subject | Anselamimab | Protein / enzyme biologic | 1000 mg/m2 | Intravenous |
| Background | Bortezomib | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Daratumumab | Monoclonal antibody | — | — |
| Background | Dexamethasone | Small molecule | — | — |