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

Inclusion criteria

• 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;
• dFLC ≥ 40 mg/L (based on central laboratory test results);
• ECOG performance status of 0 to 2;
• No active systemic infection within 2 weeks prior to leukapheresis;
• Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary);

Exclusion criteria

• 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;
• Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;
• History of malignancy within 5 years prior to signing the ICF