An Open-Label, Multi-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Relapsed or Refractory Primary Light-Chain Amyloidosis
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Voluntary provision of written informed consent and ability to comply with protocol requirements.
• Age ≥18 years, any gender.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
• Confirmed diagnosis of primary light-chain (AL) amyloidosis.
• Relapsed or refractory primary AL amyloidosis.
• Measurable hematologic disease at screening (per protocol-defined criteria).
• Involvement of ≥1 amyloid-affected organ.
• Adequate organ function meeting all protocol-specified criteria within 3 days prior to first dose.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
Qian Jia
qianjia@keymedbio.com
028-88610620
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 90
Treatments
Experimental: Low dose group(CM336)
Experimental: High dose group(CM336)
Related Therapeutic Areas
Sponsors
Leads: Keymed Biosciences Co.Ltd