CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Relapsed/Refractory B Cell Leukemia/Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
- •Eastern Cooperative Oncology Group (ECOG) performance status <2
- •ALT/ AST <3 x normal
- •Bilirubin < 2.0 mg/dl
- •Creatinine < 2.5 mg/dl and less than 2.5x normal for age
- •LVEF< 45%
- •Accept white blood cell collection
- •Provide informed consent
排除标准
- •Previous treatment with investigational gene or cell therapy medicine products
- •Active hepatitis B , hepatitis C or HIV infection
- •Uncontrolled active infection
- •Presence of grade 2-4 acute or extensive chronic GVHD
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •Received non-diagnostic purposes major surgery within the past 4 weeks
- •Participated in any other clinical study within the past 4 weeks
- •Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
- •Pregnancy or breast-feeding women
- •Use of prohibited drugs:
- •Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
- •Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion
- •GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion
- •Any situation that may increase the risk of the test or interfere with the test results
结局指标
主要结局
ORR
时间窗: 3 months
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
次要结局
- OS(1 year)
- DFS(1 year)
- ORR(12 months)
- Adverse Events(12 months)