Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients or their legal guardians must acknowledge the risks and procedures involved and subsequently provide informed consent to participate in the clinical trial. 2. Predicted survival time ≥ 12 weeks; 3. ECOG: 0\~2; 4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% ; 5. Renal function: eGFR≥30ML/min/1.73m2； (For patients with an eGFR \< 30 mL/min/1.73 m² or those receiving renal replacement therapy, inclusion or exclusion in the study is determined at the discretion of the investigators. ) 6. Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN; 7. Lung function: No serious lung lesions, SpO2≥92%; 8. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-NK infusion; SLE: 1. Age:≥5 years old; 2. Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；