Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
Summary
This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CM313. The dose escalation part will determine the MTD of CM313 in subjects with relapsed and/or refractory multiple myeloma (RRMM) or lymphoma based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design). The dose expansion part includes two cohorts. Cohort 1 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Dexamethasone in subjects with RRMM. Cohort 2 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Rd regimen (Lenalidomide/Dexamethasone) in subjects with RRMM or newly diagnosed MM (NDMM).
Timeline
- Start
- 2021-04-26
- Primary completion
- 2023-01
- Completion
- 2023-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LUMROTATUG | Monoclonal antibody | 0.006 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 0.06 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 0.3 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 1 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 2 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 4 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 8 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 16 mg/kg | — |
| Subject | LUMROTATUG | Monoclonal antibody | 24 mg/kg | — |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Lenalidomide | Other / unclassified | 25 mg | — |