this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.
Patients or their legal guardians must acknowledge the risks and procedures involved and subsequently provide informed consent to participate in the clinical trial.
Predicted survival time ≥ 12 weeks;
ECOG: 0~2;
Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% ;
Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, obinutuzumab), or subjects with a history of severe allergic reactions
Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
Subjects with grade III or IV heart failure (NYHA classification)
Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs；
Single group
anti-CD19/BCMA CAR NK cells (KN5601)
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/BCMA CAR NK cells (KN5601) will infused in each group using dose-escalation strategy.
The safety of CAR-NK cell therapy in patients with B cell mediated autoimmune disease
Incidence of Dose Limiting Toxicity (DLTs), Incidence and severity of Adverse Events (AEs) and Serious Adverse Event（SAEs）.
The efficiency of CAR-NK cell therapy in patients with B cell mediated autoimmune disease
SLE: The rate of patients achieving SRI-4 response, LLDAS, or DORIS remission MDR-SRNS:Complete response and partial response rate. IgAN:partial or complete response.
Effectiveness of other visit points
The responsive rate and the rate of complete /partial remission
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