A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease
Age: ≥ 18 years old and ≤ 70 years old, male or female;
2 B cell CD19 positive expression in peripheral blood detected by flow cytometry;
Neutrophil count ≥ 1 x 10^9/L, Hemoglobin ≥60g/L, platelets ≥ 50×109/L,
Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN,
Subjects known to have allergic reactions, hypersensitivity, intolerance, or contraindications to CD19/BCMA universal CAR-T or any drug components that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or who have previously experienced severe allergic reactions;
The subject has or is suspected of having uncontrolled or treatable fungal, bacterial, viral, or other infections;
Subjects with central nervous system disorders caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
Subjects with more serious heart conditions, such as angina, myocardial infarction, heart failure, and arrhythmias;
Single group
anti-CD19/BCMA U CAR T
Biological/VaccineTo evaluate the safety and effectiveness of anti-CD19/BCMA CAR T cells (KN3601) in patients with immune nephropathy. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19/BCMA U CAR T cells infusion.
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy
The overall response rate (ORR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
Disease control rate (DCR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
B cell depletion rate
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
B cell reconstitution
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy
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Changhai Hospital
Lead sponsor
Rui Therapeutics Co., Ltd
Collaborator
