Tests CM336 injection in adults with relapsed primary light-chain amyloidosis
Tests CM336, an antibody injection, in adults with returning primary light-chain amyloidosis.
Plain-language title generated from the registry record
Registry title: Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
Key facts
- Where
- Beijing and Tianjin, ChinaSee the 2 sites
- Phase
- Phase 2
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Keymed Biosciences Co.Ltd
- Trial code
- NCT07039578
- Record updated
- 26 November 2025
- Original description
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain AmyloidosisRead full original descriptionShow less
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: 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: 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.