Actively Recruiting
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
Led by Keymed Biosciences Co.Ltd · Updated on 2025-11-26
90
Participants Needed
2
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
CONDITIONS
Official Title
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily provided written informed consent and can comply with study requirements
- Adults aged 18 years or older of any gender
- Eastern Cooperative Oncology Group (ECOG) Performance Status between 0 and 2
- Confirmed diagnosis of primary light-chain (AL) amyloidosis
- Relapsed or refractory primary AL amyloidosis
- Measurable hematologic disease at screening as defined by the protocol
- Involvement of at least one amyloid-affected organ
- Adequate organ function within 3 days prior to first dose according to protocol criteria
You will not qualify if you...
- Current or prior diagnosis of multiple myeloma
- Received anti-AL amyloidosis therapy within the protocol-specified time frame before first dose
- Clinically significant cardiovascular or cerebrovascular disease
- Any active or uncontrolled infection as defined by the protocol
- Any other condition that the investigator considers unsafe for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
Q
Qian Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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