RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Who May Be Eligible (Plain English)
Who May Qualify:
- Voluntary provision of written willing to sign a consent form 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.
- your organs (liver, kidneys, etc.) are working well enough based on blood tests meeting all protocol-specified criteria within 3 days prior to first dose.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
CM336 Injection(Low dose group)
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
BIOLOGICAL
CM336 Injection(High dose group)
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
Locations (2)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China