CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases

Inclusion criteria

• . Age ≥ 18 years old (inclusive), regardless of gender.
• . Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; 2) Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤2×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome); 3) Renal function: creatinine clearance rate (CrCl) ≥ 30mL/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is excluded).
• . Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative human chorionic gonadotropin (hCG) test within 7 days before study enrollment and not be lactating.
• . Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
• . SLE meeting the 2019 American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) and classification criteria.
• . Disease activity score SLEDAI-2000 ≥ 8; or with significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of class III or IV, with or without class V, with an NIH activity index \> 2, evidence of increased chronicity index; urine protein-to-creatinine ratio \> 1.0 g/g, or 24-hour urinary protein \> 1.0 g).