NCT06352281招募中1 期
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)
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Portion of patients with response (R)
研究概览
简要总结
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).
详细描述
This open label and single-arm study aims to evaluate the efficacy and safety of CAR-T cells therapy in patients with Chronic or Refractory Primary Immune Thrombocytopenia (ITP). After enrollment, a leukapheresis procedure will be performed to manufacture chimeric antigen receptor (CAR) modified T cells. Patients will get a 3-5 days lymphodepletion therapy with fludarabine and cyclophosphamide, then the CAR-T cells will be infused by vein. After infusion, subjects will be followed for safety and efficacy evaluation up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
- •History of platelet agglutination abnormality that prevents reliable measurement of platelet counts;
- •Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy;
- •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;
- •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;
- •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;
- •Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;
- •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;
- •Pregnancy and lactation;
- •History of mental illness and known alcohol/drug addiction;
- •Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
- •Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
结局指标
主要结局
Portion of patients with response (R)
时间窗: At least 2 weeks after infusion
platelet count\>30x10\^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
次要结局
- Portion of patients with complete response (CR)(At least 2 weeks after infusion)
- Time (in days) from treatment start to response (R)(At least 2 weeks after infusion)
- Duration (in days) of response (R)(At least 2 weeks after infusion)
- Incidence of adverse events(AE) after infusion(Up to 12 months after infusion)
- Time (in days) from treatment to complete response (CR)(At least 2 weeks after infusion)
- Portion of patients with relapse(At least 2 weeks after infusion)
研究者
研究点 (1)
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