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

Trial details

Who runs it

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

Trial code

NCT06352281

Record updated

22 July 2024

Original description

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).Read full original descriptionShow less

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).

Inclusion: 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.

Exclusion: 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; Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study; Had undergone other clinical trials in the 4 weeks prior to participating in this trial; All subjects with diseases which may cause secondary immune thrombocytopenia; Hemostatic disorders other than chronic thrombocytopenia; Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy; History of thrombosis or presence of significant risk factors for thrombosis; 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; 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; Patients with severe history of allergy or allergic constitution; History of mental illness and known alcohol/drug addiction; 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; History of platelet agglutination abnormality that prevents reliable measurement of platelet counts; Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal); Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex; Patients with preventive splenectomy; Pregnancy and lactation; Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan.

ClinicalTrials.gov NCT06352281