CM336 Injection(Low dose group): subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
CM336 Injection(High dose group): subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
Study summary
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
To evaluate the efficacy after CM336 treatment — up to 3 years Hematologic complete response (hCR) rate
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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