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

Last updated: November 20, 2025
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Amyloidosis

Treatment

CM336 Injection(High dose group)

CM336 Injection(Low dose group)

Clinical Study ID

NCT07039578
CM336-026101
  • Ages > 18
  • All Genders

Study Summary

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

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

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: CM336 Injection(High dose group)
Phase: 2
Study Start date:
July 25, 2025
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349
    China

    Active - Recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin 1792947, Tianjin Municipality 1792943
    China

    Active - Recruiting

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