CAR-T for Autoimmune Hemolytic Anemia Patients Who Have Failed Three or More Lines of Therapy

Inclusion Criteria:

• Subject and/or subject's legal personal representative fully understand andvoluntarily sign informed consent forms.
• Male or female age ≥ 12 years.
• ECOG performance status ≤2.
• Diagnosis of warm antibody hemolytic anemia (AIHA), cold AIHA, mixed AIHA or Evanssyndrome.
• Hemoglobin<100g/L.
• Failure or intolerance to at least 3 lines of therapy, including glucocorticoids,rituximab, cyclophosphamide, azathioprine, fludarabine, cyclosporine, mycophenolatemofetil, Bruton's tyrosine kinase inhibitors, splenectomy.
• Laboratory tests of adequate organ function: Serum alanine aminotransferase (ALT) andaspartate aminotransferase (AST) ≤3×ULN; Creatinine clearance (CrCl) (Cockcroft-Gaultformula) ≥40ml/min; Absolute neutrophil count (ANC) ≥1.0×10^9/L (growth factors suchas granulocyte colony-stimulating factor [G-CSF] were not received within 7 daysbefore the screening period); Left ventricular ejection fraction (LVEF) ≥45%; Bloodoxygen saturation (SpO2) ≥92%.
• Subjects of childbearing potential will be required to follow contraceptionrequirements from the time of enrollment until the end of the 6-month safety follow-upperiod. Female subjects of childbearing potential must have a negative Serum HCG testwithin 7 days before enrollment and not in the lactation period.

Exclusion Criteria:

• Clear diagnosis of lymphoproliferative tumor.
• The platelet count in peripheral blood during the screening period is <20×10^9/L.
• Have a history of severe drug allergy or allergic constitution.
• Have a history of any of the following diseases: craniocerebral trauma, consciousnessdisorder, epilepsy, cerebrovascular ischemia, cerebrovascular, and hemorrhagicdiseases within 6 months before enrollment.
• Have any of the following serious cardiovascular diseases: myocardial infarctionwithin 6 months before enrollment, cardiac angioplasty or stent implantation);Unstable angina; Severe cardiac arrhythmias; History of severe nonischemiccardiomyopathy; Congestive heart failure (New York Heart Association [NYHA] Class IIIor IV)).
• Have malignant tumors within 5 years before enrollment, unless any of the followingconditions: fully treated cervical carcinoma in situ, fully treated basal cell orsquamous epithelial cell skin cancer, localized prostate cancer after radicalmastectomy, breast ductal carcinoma in situ after radical mastectomy, Carcinoma insitu in other locations one year after radical resection, and these diseases have noevidence of relapse.
• Subjects with any serious active fungal, bacterial, viral, tuberculosis or otherinfections, including active hepatitis B (defined as serum HBV-DNA ≥ 2000 IU/mL),active hepatitis C virus (Hepatitis C virus (HCV) infection, human immunodeficiencyvirus (HIV) antibody-positive or active syphilis patients, etc. Subjects whose HBV-DNA < 2000 IU/mL can be included on the condition that they receive antiviral drugs andmonitor the related indicators during the study.
• Have mental illness and severe cognitive impairment.
• Have a history of live attenuated vaccines within 4 weeks before enrollment.
• Subjects considered to be ineligible for the study by the investigator for reasonsother than the above.