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
Keymed Biosciences Co.Ltd
90 participants
Jul 25, 2025
INTERVENTIONAL
Conditions
Summary
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Eligibility
Inclusion Criteria8
- 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 Criteria5
- 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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Interventions
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07039578