A Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia

Exclusion Criteria

• •Diagnosis of lymphoproliferative tumor
• •Other hereditary or acquired hemolytic diseases (Secondary AIHA caused by drugs or infection)
• •The platelet count in peripheral blood\<30×10\^9/L
• •Pregnant or breast-feeding subjects
• •Receive any of the following treatments within the specified time before cell infusion: a.anti-CD20 monoclonal antibodies \<12 weeks, b.sutimlimab or other marketed biologics \<5 half-lives,c.plasma exchange \<4 weeks, d.post-splenectomy \<12 weeks, e. BTK inhibitors, anti-CD38 monoclonal antibody, Syk inhibitors, BAFF inhibitors \< 5 half-lives.
• •Previously received organ or stem cell transplantation
• •History of new thrombosis or organ infarction in the past 6 months
• •Diagnosis of the active stage of the connective tissue disease.
• •Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.
• •Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.
• •Underwent major surgery within 4 weeks before screening, as determined by the investigator to be unsuitable for enrollment.
• •Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.
• •Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)), c.severe arrhythmias requiring treatment, d.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, e.other heart diseases judged by the researcher to be unsuitable for enrollment.
• •Have a history of live attenuated vaccines within 6 weeks before enrollment.
• •Have a history of epilepsy or other active central nervous system diseases.
• •Have an allergy to the ingredients of the medicine used in this study.
• •Previously received CAR-T cell therapy.
• •Patients considered to be ineligible for the study by the investigator for reasons other than the above.