Clinical Trial

Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Genetic Stratification

Study acronym: AL-005
Not Yet Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This study is a prospective, single-center, phase Ib/II clinical trial designed to evaluate the tolerability of sonrotoclax plus dexamethasone in this phase Ib/II umbrella study and to determine the recommended phase II dose (RP2D). It also aims to assess the safety and hematologic response rate of sonrotoclax plus dexamethasone in patients with newly diagnosed systemic light-chain amyloidosis (NDAL) harboring t(11;14), and of a BCMA/CD3 bispecific antibody in patients with NDAL without t(11;14). In addition, this study seeks to explore a chemotherapy-free treatment strategy based on t(11;14)-guided genetic stratification.
Trial Details
NCT Number NCT07687004
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Multiple Myeloma (MM)
Enrollment 50 participants
Start Date 2026-08-01
Primary Completion 2027-08-01 (estimated)
Study Completion 2029-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-07