NCT04818372

Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma

A Phase I, Multiple Center, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma
• Lymphoma

Interventions

Type	Name	Description
DRUG	CM313-Dose escalation	Subjects will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals.
DRUG	CM313	Subjects will have 8 infusions at weekly intervals, and then 8 infusions at bi-weekly intervals. After that CM313 will be given every 4 weeks until disease progression or unacceptable toxicity.
DRUG	Dexamethasone	dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
DRUG	Lenalidomide	25 mg/day lenalidomide 21 of 28 days cycle

Timeline

• Start date: 2021-04-26
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2021-03-26
• Last updated: 2021-11-12

Locations

3 sites across 1 country: China