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

Inclusion Criteria:

1. Willingness to complete the informed consent process and to comply with studyprocedures and visit schedule;

2. Men and women aged 8-75;

3. Participants diagnosed with chronic (>12 months duration) or refractory (adocumented intolerance or insufficient response to the first and second linestandard treatment of ITP) ITP;

4. The results of physical, instrumental, and laboratory examination of patients notsuggest any disease which may cause thrombocytopenia other than ITP;

5. Platelet count <30 x 109 / L;

6. If the patient is taking corticosteroids, the treatment regimen/dose should bestable (at least 2 weeks prior to screening);

7. The results of physical, instrumental, and laboratory examination of patients shouldbe within the normal range or deviations should be regarded by the researcher asclinically insignificant;

8. Willingness to use effective and reliable methods of contraception throughout theentire study period;

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 limitedto aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive dayswithin 2 weeks of the study start and until the end of the study;

5. History of platelet agglutination abnormality that prevents reliable measurement ofplatelet counts;

6. Concurrent malignant disease and/or history of cancer treatment with cytotoxicchemotherapy and/or radiotherapy;

7. Grade III-IV heart failure or myocardial infarction, cardiac angioplasty orstenting, unstable angina pectoris, or other clinically prominent heart diseasewithin 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 tractassociated with the risk of bleeding, acute infectious diseases, pathologies of therespiratory system;

10. Any clinically significant hepatic impairment (increase of serum transaminase levelsby more than 3 times the upper limit of normal);

11. Serum creatinine levels are more than two times higher than the upper limit ofnormal for a given age and sex;

12. Any other concomitant decompensated diseases or acute conditions, the presence ofwhich, according to the researcher, may significantly affect the results of thestudy;

13. Human immunodeficiency virus (HIV) seropositivity, Hepatitis B surface antigenpositive or hepatitis B core antibody positive and HBV-DNA positive, Patients withhepatitis C (HCV-RNA quantitative test results positive), Or the presence of otherserious active viral or bacterial infections or uncontrolled systemic fungalinfections;

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 otherfactors, 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 thistrial;