OncoMatch/Clinical Trials/NCT05978661
FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Is NCT05978661 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies FKC288 for light chain amyloidosis.
Treatment: FKC288 — This study is a single-center exploratory clinical trial. It is estimated that 6-12 subjects will be enrolled. The "BOIN" dose escalation design is adopted. The main purpose is to evaluate the safety of FKC288 in the treatment of subjects with relapsed or refractory AL amyloidosis and explore the recommended phase II dose of FKC288 in the treatment of patients with relapsed/refractory systemic Light Chain (AL) amyloidosis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: gene therapy
Cannot have received: live vaccines
Cannot have received: other interventional clinical research drugs
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.0×10^9/L (no G-CSF within 7 days before exam); Platelet count ≥ 75×10^9/L (no transfusion or TPO within 7 days before exam); Hemoglobin ≥ 9 g/dl (no transfusion within 7 days before exam)
Kidney function
Creatinine clearance rate ≥ 40 ml/min
Liver function
Bilirubin ≤ 1.5× ULN (except bile duct obstruction caused by tumor compression); ALT or AST ≤ 2.5× ULN (≤5× ULN in patients with liver involvement)
Cardiac function
Left ventricular ejection fraction ≥ 50% with no significant pericardial effusion; NTproBNP < 1800pg/ml, TNT < 0.06ng/ml
Before enrollment, the subject must have appropriate organ function and meet all the following criteria: 1) Absolute neutrophil count ≥ 1.0×10^9/L (use of granulocyte colony-stimulating factor (G-CSF) support is allowed, but must be without supportive treatment within 7 days before the examination); 2) Platelet count ≥ 75×10^9/L (no transfusion support [including component transfusion] or treatments aimed at raising platelets such as thrombopoietin [TPO] should be received within 7 days before the examination); 3) Hemoglobin ≥ 9 g/dl (no transfusion support [including component transfusion] should be received within 7 days before the examination); 4) Bilirubin value ≤ 1.5× upper limit of normal (ULN) (except bile duct obstruction caused by tumor compression); 5) Creatinine clearance rate ≥ 40 ml/min; 6) ALT or AST ≤ 2.5× ULN (≤5 times the upper limit of normal in patients with liver involvement); 7) Echocardiography results indicate left ventricular ejection fraction ≥ 50% with no significant pericardial effusion; 8) NTproBNP < 1800pg/ml, TNT < 0.06ng/ml; 9) Stable coagulation function: INR ≤ 1.5, APTT ≤ 1.2× ULN (excluding tumor-related anticoagulant therapy); 10) >95% basic blood oxygen saturation in the natural indoor air environments.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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