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: 1. Voluntarily signed the informed consent form (ICF); 2. Aged between 18-75 years old (inclusive); 3. Confirmed clinical diagnosis of primary light chain (AL) amyloidosis; 4. Relapsed or refractory disease; 5. dFLC ≥ 40 mg/L (based on central laboratory test results); 6. ECOG performance status of 0 to 2; 7. No active systemic infection within 2 weeks prior to leukapheresis; 8. Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary); Exclusion Criteria: 1. Presence of any clinically significant cardiovascular disease within 6 months prior to screening; 2. Clinically significant central nervous system (CNS) disease or pathological abnormality; 3. History of solid organ transplantation (e.g., heart, lung, kidney, liver); 4. Presence of complete intestinal obstruction; 5. Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage; 6. History of malignancy within 5 years prior to signing the ICF