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

ConditionPrimary 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

CM336 Injection(Low dose group)
Biological/Vaccine
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.
CM336 Injection(High dose group)
Biological/Vaccine
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Low dose group(CM336)Experimental treatment 1 intervention

Group B: High dose group(CM336)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

To evaluate the efficacy after CM336 treatment

Hematologic complete response (hCR) rate

Time frame

up to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keymed Biosciences Co.Ltd

Lead sponsor

Source ClinicalTrials.gov

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