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

Launched by KEYMED BIOSCIENCES CO.LTD · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CM336, which is an injection designed to help adults with a condition called primary light-chain amyloidosis. This is a rare disease where abnormal proteins build up in the body’s organs and tissues, causing damage. The study aims to see if CM336 is safe to use and if it can help people whose disease has returned after previous treatment or who haven’t responded well to other therapies.

Adults aged 18 and older with confirmed primary light-chain amyloidosis who have active disease affecting at least one organ may be eligible to join. Participants need to be well enough to take part, with a certain level of overall health, and must not have certain other serious health conditions like multiple myeloma or uncontrolled infections. If accepted, participants will receive CM336 injections and be closely monitored to check how well the treatment is working and to watch for any side effects. This study is currently recruiting, so people interested should talk to their doctor to see if they qualify and to learn more about what taking part would involve.

Gender

ALL

Eligibility criteria

• 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 symptomatic 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.