Primary Light-Chain Amyloidosis
Conditions
Brief summary
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Interventions
BIOLOGICALCM336 Injection(Low dose group)
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
BIOLOGICALCM336 Injection(High dose group)
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy after CM336 treatment | up to 3 years | Hematologic complete response (hCR) rate |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed