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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeymed Biosciences Co.Ltd

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CM336 Injection(Low dose group)
  • CM336 Injection(High dose group)

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators