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

Keymed Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Primary Light-Chain Amyloidosis

Treatments: Biological: CM336 Injection(High dose group); Biological: CM336 Injection(Low dose group)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07039578

CM336-026101

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Low dose group(CM336)

Experimental group

Treatment:

Biological: CM336 Injection(Low dose group)

High dose group(CM336)

Experimental group

Treatment:

Biological: CM336 Injection(High dose group)