drugset / Trial / NCT05145816
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Phase 1/2
Recruiting
37 enrolled
University of Texas Southwestern Medical Center
GlaxoSmithKline · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1
Timeline
- Start
- 2024-02-15
- Primary completion
- 2027-03-01
- Completion
- 2027-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belantamab mafodotin | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Belantamab mafodotin | Monoclonal antibody | 1.4 mg/kg | Intravenous |
| Subject | Belantamab mafodotin | Monoclonal antibody | 1.9 mg/kg | Intravenous |
| Subject | Belantamab mafodotin | Monoclonal antibody | 2.5 mg/kg | Intravenous |