drugset / Trial / NCT05299424
A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma. This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ). The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined. The efficacy of CM336 will be evaluated in Phase 2 study.
Timeline
- Start
- 2022-08-09
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CM336 | Monoclonal antibody | 0.04 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 0.2 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 1 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 2 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 3 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 4 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 5 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 15 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 24 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 60 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | CM336 | Monoclonal antibody | 90 mg | Subcutaneous |