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

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

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

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.