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

Locations

1
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China650000, KunmingYunnan, China

Sponsors and collaborators

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Lead sponsor