FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Inclusion Criteria:

1. The subject must personally sign a written informed consent form approved by theethics committee before the start of the study;
2. The subject's age is ≥18 years old and <70 years old;
3. The subject must be diagnosed with light chain amyloidosis by pathologicalexamination, with at least one major organ involved (heart, kidney, or liver);
4. The subject with recurrent/refractory light chain amyloidosis that achieved noresponse with conventional treatment;
5. dFLC > 50mg/L;
6. Expected survival ≥ 12 weeks;
7. ECOG score ≤ 2 points;
8. Female subjects with fertility should agree to practice an effective method ofcontraception from the day of signing the ICF until 365 days after the infusion. Aneffective method of contraception is defined as abstinence or contraceptive methodswith an annual failure rate of <1% specified in the plan.
9. Before enrollment, the subject must have appropriate organ function and meet all thefollowing criteria:

1. Absolute neutrophil count ≥ 1.0×109/L (use of granulocyte colony-stimulating factor (G-CSF) support is allowed, but must be without supportive treatment within 7 days beforethe examination); 2) Platelet count ≥ 75×109/L (no transfusion support [including componenttransfusion] or treatments aimed at raising platelets such as thrombopoietin [TPO] shouldbe received within 7 days before the examination); 3) Hemoglobin ≥ 9 g/dl (no transfusionsupport [including component transfusion] should be received within 7 days before theexamination); 4) Bilirubin value ≤ 1.5× upper limit of normal (ULN) (except bile ductobstruction caused by tumor compression); 5) Creatinine clearance rate ≥ 40 ml/min; 6) ALTor AST ≤ 2.5× ULN (≤5 times the upper limit of normal in patients with liver involvement);
2. Echocardiography results indicate left ventricular ejection fraction ≥ 50% with nosignificant pericardial effusion; 8) NTproBNP < 1800pg/ml, TNT < 0.06ng/ml; 9) Stablecoagulation function: INR ≤ 1.5, APTT ≤ 1.2× ULN (excluding tumor-related anticoagulanttherapy); 10) >95% basic blood oxygen saturation in the natural indoor air environments.

Exclusion Criteria:

1. Subjects who have received any of the following treatments prior to enrollment: 1)Subjects who have received gene therapy before enrollment; 2) Subjects who havereceived live vaccines within 4 weeks prior to enrollment; 3) Subjects has receivedother interventional clinical research drugs within 12 weeks before apheresis.
2. Subjects with central metastasis or complete intestinal obstruction.
3. Subject with moderate or more severe hydrothorax and ascites which are hard to controlby conventional treatment and require continuous catheter drainage.
4. With an active malignant tumor in the past 5 years, unless it is a curable tumor andhas been obviously cured.
5. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B coreantibody (HBcAb) and have abnormal peripheral blood HBV DNA test results (HBV DNA testabnormality is defined as HBV DNA quantitative detection is higher than the detectioncenter's detection lower limit or higher than the detection center's normal referencerange or HBV DNA qualitative detection is positive); hepatitis C virus (HCV) antibodypositive and peripheral blood hepatitis C virus (HCV) RNA positive; humanimmunodeficiency virus (HIV) antibody positive; the cytomegalovirus (CMV) DNApositive; syphilis testing RPR positive.
6. Presence of uncontrollable active infections (excluding <CTCAE grade 2 urinary andrespiratory tract infections).
7. Severe cardiovascular diseases, including but not limited to unstable angina pectoris,myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), and severe arrhythmias.
8. Subjects with hypertension that cannot be controlled by medication.
9. Toxicity reactions that have not been relieved to baseline or ≤ grade 1 (NCI-CTCAEversion 5.0, except for hair loss and laboratory test abnormalities without clinicalsignificance) from past treatments.
10. Major surgery within 2 weeks before enrollment, or has a surgery planned during thetime the subject is expected to be infused with FKC288 or within 12 weeks after FKC288infusion (except planned surgery under local anesthesia).
11. Subject who has a solid organ transplant.
12. Women who are pregnant or breastfeeding.
13. Subjects with previous central nervous system diseases (such as cerebral aneurysm,epilepsy, stroke, dementia, psychosis, etc.) or conscious disorders.
14. Other systemic diseases that the investigator judges as unstable, including but notlimited to severe liver, kidney, or metabolic diseases that require medication.
15. Known life-threatening allergic reactions, hypersensitivity reactions, or intoleranceto FKC288 cell preparations or their components.
16. Subjects judged by the investigator to have bleeding or severe thrombosis, or haveinherited/acquired bleeding and severe thrombosis (including hemophilia, coagulationdysfunction, thrombocytopenia, splenomegaly, etc.), or are receiving thrombolysis oranticoagulation therapy.
17. Other situations deemed inappropriate for inclusion by the investigator.