A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)
Aged 18 to 75 years inclusive, either gender;
Absolute neutrophil count ≥ 1.0 × 10⁹/L, hemoglobin ≥ 60 g/L, platelet count ≥ 50 × 10⁹/L;
Hepatic function: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN;
Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
Subjects with known allergic reaction, hypersensitivity, intolerance, or contraindication to CD19/BCMA universal CAR-T or any components of the study drugs (including fludarabine, cyclophosphamide, and tocilizumab), or a history of severe allergic reaction in the past.
Presence or suspicion of uncontrolled or treatable fungal, bacterial, viral, or other infections.
Central nervous system diseases caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
Subjects with severe cardiac diseases, such as angina pectoris, myocardial infarction, heart failure, arrhythmia, etc.
Single group
CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing
DrugPatients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Single dose of CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (KN3601) will infused using dose-escalation strategy.
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy
The overall response rate (ORR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy
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This trial is not recruiting at the moment. You can still explore other options:
