Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
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).