A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Primary AL Amyloidosis

This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory primary light chain (AL) amyloidosis.The primary objectives are to assess the safety of FKC289 and to establish the recommended Phase II dose (RP2D). And this Phase II study is designed to evaluate the efficacy of FKC289.The primary objectives are to assess proportion of subjects with hematologically best complete response (CR) within 6 months.

NCT Number	NCT07765524
Lead Sponsor	Shenzhen Fosun Kairos Biotechnology Co., Ltd.
Conditions	Primary Light Chain (AL) Amyloidosis
Enrollment	32 participants
Start Date	2026-08
Primary Completion	2028-03 (estimated)
Study Completion	2029-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-14