Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)

Exclusion Criteria18

• All subjects with diseases which may cause secondary immune thrombocytopenia
• Patients with preventive splenectomy;
• Hemostatic disorders other than chronic thrombocytopenia;
• Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for \> 3 consecutive days within 2 weeks of the study start and until the end of the study;
• History of platelet agglutination abnormality that prevents reliable measurement of platelet counts;
• Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy;
• Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
• History of thrombosis or presence of significant risk factors for thrombosis;
• Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system;
• Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal);
• Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;
• Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;
• Human immunodeficiency virus (HIV) seropositivity, Hepatitis B surface antigen positive or hepatitis B core antibody positive and HBV-DNA positive, Patients with hepatitis C (HCV-RNA quantitative test results positive), Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections;
• Patients with severe history of allergy or allergic constitution;
• Pregnancy and lactation;
• History of mental illness and known alcohol/drug addiction;
• Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
• Had undergone other clinical trials in the 4 weeks prior to participating in this trial;