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.
Voluntarily signed the informed consent form (ICF);
Aged between 18-75 years old (inclusive);
Confirmed clinical diagnosis of primary light chain (AL) amyloidosis;
Relapsed or refractory disease;
Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
Clinically significant central nervous system (CNS) disease or pathological abnormality;
History of solid organ transplantation (e.g., heart, lung, kidney, liver);
Presence of complete intestinal obstruction;