RecruitingPhase 2NCT07039578

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

Sponsor

Keymed Biosciences Co.Ltd

Enrollment

90 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Light-Chain Amyloidosis

Summary

to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CM336 Injection(High dose group) and a biological treatment called CM336 Injection(Low dose group) for people with primary light-chain amyloidosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07039578