About this trial
It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP).
Eligibility criteria
Qualifiers
Willingness to complete the informed consent process and to comply with study procedures and visit schedule;
Men and women aged 8-75;
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;
The results of physical, instrumental, and laboratory examination of patients not suggest any disease which may cause thrombocytopenia other than ITP;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- CAR-T cells