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

RecruitingPhase 2Ages 18 Years - anyAllKeymed Biosciences Co.Ltd
NCT07039578 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • CM336 Injection(Low dose group)
  • CM336 Injection(High dose group)
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Where

2 sites
Peking Union Medical College Hospital
Beijing, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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