A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cell injection (KN5501) in patients with immune nephropathy. 36 patients are planned to be enrolled in the dose-escalation trial. The primary endpoints are DLT and TEAEs. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR)
Age: ≥ 18 years old and ≤ 70 years old, male or female;
Positive CD19 expression in peripheral blood B cells as determined by flow cytometry;
Bone marrow hematopoietic function: a. White blood cell count ≥ 3 x 10^9/L b. Neutrophil count ≥ 1 x 10^9/L (no colony-stimulating factor treatment within 2 weeks before examination); c. Hemoglobin ≥60g/L.
Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN(excluding Gilbert syndrome, total bilirubin ≤ 3.0 x ULN)
Individuals with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;
Individuals with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
Individuals with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
Single group
anti-CD19 CAR NK cells
Biological/VaccinePatients will receive Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Multiple doses of anti-CD19 CAR NK cells (KN5501) will infused in each group using the "3 + 3" dose-escalation strategy.
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of anti-CD19 CAR NK Cells (KN5501) for Relapsed/Refractory Immune Nephropathy
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of anti-CD19 CAR NK Cells (KN5501) for Relapsed/Refractory Immune Nephropathy
The overall response rate (ORR)
To characterize the efficacy of anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy
Disease control rate (DCR)
To characterize the efficacy of anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy
B cell depletion rate
To characterize the efficacy of anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy
B cell reconstitution
To characterize the efficacy of anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory Immune Nephropathy
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Changhai Hospital
Lead sponsor
Rui Therapeutics Co., Ltd
Collaborator
