Clinical Trial

BCMA/GPRC5D Trispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-004)

Study acronym: AL-004
Not Yet Recruiting Phase 2
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Summary
Systemic light-chain (AL) amyloidosis is a plasma cell disorder characterized by the production of misfolded immunoglobulin light chains that deposit in organs and lead to progressive organ dysfunction. Although daratumumab-based therapy has improved outcomes, a substantial proportion of patients fail to achieve deep hematologic responses. This is a prospective, single-arm, single-center clinical study evaluating the safety and efficacy of the BCMA/GPRC5D/CD3 trispecific antibody QLS4131 in patients with newly diagnosed systemic AL amyloidosis.
Trial Details
NCT Number NCT07751471
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions AL Amyloidosis
Enrollment 20 participants
Start Date 2026-07-20
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-07