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
1 other identifier
interventional
90
1 country
2
Brief Summary
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2025
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
June 26, 2025
CompletedStudy Start
First participant enrolled
July 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
November 26, 2025
November 1, 2025
11 months
June 18, 2025
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy after CM336 treatment
Hematologic complete response (hCR) rate
up to 3 years
Study Arms (2)
Low dose group(CM336)
EXPERIMENTALHigh dose group(CM336)
EXPERIMENTALInterventions
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Li
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Gang An
Institute of Hematology & Blood Diseases Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2025
First Posted
June 26, 2025
Study Start
July 25, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 31, 2029
Last Updated
November 26, 2025
Record last verified: 2025-11