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

Exclusion Criteria

• •1. All subjects with diseases which may cause secondary immune thrombocytopenia
• •2. Patients with preventive splenectomy;
• •3. Hemostatic disorders other than chronic thrombocytopenia;
• •4. 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;
• •5. History of platelet agglutination abnormality that prevents reliable measurement of platelet counts;
• •6. Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy;
• •7. 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;
• •8. History of thrombosis or presence of significant risk factors for thrombosis;
• •9. 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;
• •10. Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal);
• •11. Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;
• •12. Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;
• •13. 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;
• •14. Patients with severe history of allergy or allergic constitution;
• •15. Pregnancy and lactation;
• •16. History of mental illness and known alcohol/drug addiction;
• •17. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
• •18. Had undergone other clinical trials in the 4 weeks prior to participating in this trial;