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Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis

NCT07039578 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-26

No results posted yet for this study

Summary

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

Conditions

  • Primary Light-Chain Amyloidosis

Interventions

BIOLOGICAL

CM336 Injection(Low dose group)

subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.

BIOLOGICAL

CM336 Injection(High dose group)

subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.

Sponsors & Collaborators

  • Keymed Biosciences Co.Ltd

    lead INDUSTRY

Principal Investigators

  • Jian Li · Peking Union Medical College Hospital

  • Gang An · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2026-06-30
Completion
2029-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039578 on ClinicalTrials.gov