BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a prospective, single-arm, single-center clinical study designed to evaluate the efficacy and safety of low-dose BCMA/CD3 bispecific antibody (CM336) in patients newly diagnosed with systemic light chain (AL) amyloidosis.

Eligibility criteria

Qualifiers

The patient is informed of and voluntarily signs the informed consent form (ICF).

Age ≥18 years, regardless of sex.

Confirmed diagnosis of primary light-chain (AL) amyloidosis, in accordance with the Guidelines for the Diagnosis and Treatment of Systemic Light-chain Amyloidosis (2021 Revision).

Difference between involved and uninvolved free light chains (dFLC) ≥50 mg/L, or

Disqualifiers

None

Trial design

Treatments tested in this trial

  • anti-BCMA/CD3 bispecific antibody

Treatment groups

21 Participants
are divided into 1 treatment group