Phase
Condition
Amyloidosis
Treatment
CM336 Injection(High dose group)
CM336 Injection(Low dose group)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary provision of written informed consent and ability to comply with protocolrequirements.
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 priorto first dose.
Exclusion
Exclusion Criteria:
Current or prior diagnosis of multiple myeloma.
Received anti-AL amyloidosis therapy within protocol-specified timeframe prior tofirst 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.
Study Design
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing 1816670, Beijing Municipality 2038349
ChinaActive - Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin
ChinaSite Not Available
Institute of Hematology & Blood Diseases Hospital
Tianjin 1792947, Tianjin Municipality 1792943
ChinaActive - Recruiting

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