NCT05381181尚未招募1 期
Clinical Study of the Safety and Efficacy of Next-generation Universal CD19 Chimeric Antigen Receptor T Cells in the Treatment of Relapsed or Refractory B Cell Malignancies
Bioray Laboratories0 个研究点目标入组 20 人开始时间: 2023年12月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Dose Limiting Toxicities (DLTs) incidence
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Next-generation CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.
详细描述
CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC. This is an open-label, single arm study to evaluate the safety and anti- tumor efficacy of Next-generation CD19-UCART in the treatment of relapsed or refractory B-cell hematological malignancies.
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
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary to participate in this clinical study and sign informed consent form;
- •The expected survival period is at least three months;
- •There is no other severe cardiopulmonary disease, and the liver and kidney function are normal (except for the subject with tumor lesions in the liver and kidney);
- •Patients cannot benefit from autologous CAR-T cell therapy due to T cell separation failure or CART amplification failure in the preparation of autologous CART, or the failure to complete apheresis or disease progression; Or the content of T cells in PBMC of peripheral blood is less than or equal to 10%; Or the disease is not effectively controlled within one month after autologous CAR-T transfusion, and the patient cannot receive CAR-T transfusion again;
- •The test results show that CD19 is positive in the tumor;
- •Patients with relapsed or refractory CD19-positive acute B-lymphocyte leukemia or B-cell non-Hodgkin's lymphoma. Patients with r/r B-ALL: 1 years old ≤ patient age ≤60 years. Patients with r/r B-NHL: 18 years old ≤ patient age ≤65 years old
- •Hematological indicators meet the following conditions: 1) WBC count ≥ 1.5× 10^9/L; 2) Absolute value of neutrophils ≥ 0.8× 10^9/L; 3) Lymphocyte count ≥ 0.1× 10^9/L; 4) Hemoglobin ≥ 60 g/L; 5) Platelet count ≥ 20× 10^9/L;
- •Blood biochemistry shall meet the following requirements 1) or 2): 1) patients with liver and kidney without tumor lesions: A) Total bilirubin (TBIL)≤1.5*ULN (upper limit of normal value), unless suffering from Gilbert's syndrome; B) aspartate aminotransferase (AST) ≤ 1.5 * ULN; C) ALT ≤ 1.5 * ULN; D) Scr ≤ 1.5 * ULN; E) Urea (URA) ≤ 1.5 * ULN; 2) patients with liver and kidney tumor lesions: a) TBIL≤5*ULN； b) AST≤5*ULN； c) ALT≤5*ULN； d) SCr≤5*ULN； e) Urea≤5*ULN；
- •Heart function: good hemodynamic stability, and the left ventricular ejection fraction (LVEF) is higher than or equal to 55%;
- •Serum viruses such as HIV, TP, HBV(HBV-DNA) and HCV(HCV-DNA) are all negative;
- •ECOG activity status score: 0-2 points;
- •Accept the requirement that effective contraception be used throughout the study;
- •Willing to abide by the rules established in this study.
排除标准
- •Pregnant or lactating women;
- •Having a pregnancy plan in the next two years;
- •Has received graft-versus-host disease treatment in the past;
- •Has received allogeneic cell therapy in the past 6 weeks;
- •Has received allogeneic stem cell transplantation within the past 6 months;
- •Individual extramedullary relapse B-ALL;
- •Suffering from severe mental disorder;
- •Active autoimmune diseases requiring immunotherapy;
- •Has suffered from other malignant tumors in the past;
- •Patients with severe cardiovascular disease;
- •Prothrombin time or activated partial thromboplastin time or international normalized ratio > >1.5*ULN； in the absence of anticoagulant therapy;
- •There is active infectious disease or need any major infection events of high-level antibiotics;
- •Any condition that, in the opinion of the investigator, may increase the subject's risk or interfere with the study results.
结局指标
主要结局
Dose Limiting Toxicities (DLTs) incidence
时间窗: Day 0 up to 35 days after T cell infusion
Incidence of adverse events (AEs) defined as DLTs
次要结局
- Objective Response Rate (ORR)(At 12 weeks)
研究者
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