An Investigator-initiated Trial to Evaluate the Efficacy and Safety of CAR-T Cells Therapy in the Treatment of Chronic or Refractory Primary Immune Thrombocytopenia (ITP)
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).
• 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;
• Platelet count \<30 x 109 / L;
• If the patient is taking corticosteroids, the treatment regimen/dose should be stable (at least 2 weeks prior to screening);
• 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;
• Willingness to use effective and reliable methods of contraception throughout the entire study period;