Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis

Recruiting now · Phase 2

Conditions studied: Primary Light-Chain Amyloidosis

In brief

to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis

Key facts

Study ID

NCT07039578

Run by

Keymed Biosciences Co.Ltd

People needed

90

Starts

2025-07-25

Expected to finish

2029-07-31

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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