CM336 Injection(Low dose group)
Biologicalsubcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
Recruiting
NCT Number: NCT07039578
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Peking Union Medical College Hospital, Beijing, Beijing Municipality, China
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Current or prior diagnosis of multiple myeloma.
- Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose.
- Clinically significant cardiovascular or cerebrovascular disease.
- Any active or uncontrolled infection meeting protocol-defined criteria.
- Any other condition deemed by the Investigator to preclude safe study participation.
Treatment and study plan
CM336 Injection(High dose group)
Biologicalsubcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
Primary outcomes
-
To evaluate the efficacy after CM336 treatment
Time frame: up to 3 years
Hematologic complete response (hCR) rate
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Keymed Biosciences Co.Ltd
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2029
- First posted
- Jun 26, 2025
- Registry last updated
- Nov 26, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.