A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases

Inclusion criteria

• Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
• Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
• Age: ≥ 18 years old and ≤ 70 years old, male or female
• Subjects with estimated survival > 12 weeks
• Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)
• ECOG performance ≤ 2
• Left ventricular ejection fraction (LVEF) ≥ 45%
• Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment

Exclusion criteria

• Subjects 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
• Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
• Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
• Subjects with grade III or IV heart failure (NYHA classification)
• History of epilepsy or other central nervous system (CNS) diseases
• History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors
• Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
• Subjects were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment
• Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months
• Females who are pregnant, lactating, or planning a pregnancy within six months
• Subjects who have received other clinical trial treatment within 3 months
• Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome