CAR-T cell therapy for chronic or refractory immune thrombocytopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of CAR-T cell therapy in patients suffering from chronic or refractory primary immune thrombocytopenia (ITP). Participants will undergo a leukapheresis procedure to manufacture CAR-modified T cells, followed by a lymphodepletion therapy with fludarabine and cyclophosphamide. The CAR-T cells will then be infused into the patients, who will be monitored for safety and efficacy for up to 12 weeks, with extended follow-up for those achieving durable remission. The study is designed to assess the potential of this innovative therapy in managing a challenging hematological condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willingness to complete the informed consent process and to comply with study procedures and visit schedule;
2. Men and women aged 8-75;
3. Participants diagnosed with chronic (\>12 months duration) or refractory (a documented intolerance or insufficient response to the first and second line standard treatment of ITP) ITP;
4. The results of physical, instrumental, and laboratory examination of patients not suggest 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 be stable (at least 2 weeks prior to screening);
7. The results of physical, instrumental, and laboratory examination of patients should be within the normal range or deviations should be regarded by the researcher as clinically insignificant;
8. Willingness to use effective and reliable methods of contraception throughout the entire 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 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;

Where it's running

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
  Kunming, Yunnan, China Recruiting

Study contacts

• Principal investigator: Sanbin Wang, Doctor — 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Study coordinator: Sanbin Wang, Doctor
• Email: sanbin1011@163.com
• Phone: 13187424131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.