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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age8-75
Sponsor920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

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

Treatment groups

10 Participants
are divided into 1 treatment group