NCT04697290暂停早期 1 期
A Study of CD19/CD20 Dual CAR-T Cells in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma(B-NHL)
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 暂停
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of adverse events
研究概览
简要总结
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory or relapsed B-NHL.
详细描述
This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B-NHL. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-NHL.
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 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •NHL confirmed by cytology or histology, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, etc.
- •Relapse or refractory after at least second-line treatment;
- •With evaluable target lesions.Measurable target lesions: lymph nodes>1.5x1.0cm, extranodal lesions>1.0x1.0cm;
- •Double positive expression of CD19 / CD20 in B cells;
- •ECOG score 0-2 points;
- •Good organ function:
- •Blood routine: absolute neutrophil count (ANC) ≥1.0×109/L; hemoglobin (Hb) ≥80 g/L; platelet count (PLT) ≥50×109/L; Blood biochemistry: total bilirubin≤3×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×upper limit of normal (ULN); Pulmonary function: ≤CTCAE Grade 1 dyspnea and SaO2≥92% in indoor air environment; Heart function: Left ventricular ejection fraction (LVEF) ≥50%.
- •Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;
- •Patients who voluntarily sign informed consent and are willing to comply with treatment plans.
排除标准
- •Active infections that are difficult to control;
- •Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody positive, and Treponema pallidum antibody test positive;
- •The tumor invades the central nervous system or primary CNS lymphoma;
- •Anti-GVHD (acute or chronic) treatment is being performed within 4 weeks before apheresis and cell infusion;
- •Have undergone the following treatments:
- •Those who have received chemotherapy or radiotherapy 5 days before apheresis;
- •Those who have used drugs that stimulate the production of bone marrow hematopoietic cells within 5 days before apheresis;
- •Received donor lymphocyte infusion (DLI) within 6 weeks before cell infusion;
- •Have received autologous hematopoietic stem cell transplantation (HSCT) 3 months before apheresis, or received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 12 months;
- •Have used any gene therapy products before;
- •History of epilepsy or other central nervous system diseases; or clinically diagnosed as having severe thyroid dysfunction; or active autoimmune diseases;
- •History of other malignant tumors that have not been remission for at least 3 years ;
- •Any of the following cardiovascular diseases occurred within 6 months of the screening period, including NYHA heart function grade III or IV heart failure, cardiovascular angioplasty or stent, myocardial infarction, unstable angina, or other clinical symptoms Significant heart disease;
- •Pregnant or lactating women;
- •The investigator believes that there are other factors that are not suitable for selection or that affect subjects' participation or completion of the study.
结局指标
主要结局
Percentage of adverse events
时间窗: 6months
Percentage of participants with adverse events.
Objective remission rate(ORR)
时间窗: 6 months
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
次要结局
- Relapse-Free Survival(RFS )(6 months)
- Overall-Survival(OS)(6 months)
研究者
研究点 (1)
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