NCT02822326Unknown1 期
CD19-CAR-T2 Cells for Relapse/Refractory CD19 Positive Acute Leukemia-a Phase I Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose(MTD) of CD19 positive relapsed/ refractory acute leukimia treated wtih CD19-CAR-T2 cells
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.
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
- 14 Years 至 65 Years（Child, 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 positive B-cell acute leukemia
- •Eastern Cooperative Oncology Group (ECOG) performance status 《 3
- •ALT/ AST 《 3x 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
- •Solitary extramedullary relapse
- •Active hepatitis B , hepatitis C or HIV infection
- •Uncontrolled active infection
- •Presence of grade 2-4 acute or extensive chronic GVHD
- •Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
- •Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
- •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
- •Chemotherapy: i. The following drugs must be stopped > 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate <25 mg/m2, cytosine arabinoside < 10 mg/m2/day, asparaginase; ii. The following drugs must be stopped > 4 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs
- •Any situation that may increase the risk of the test or interfere with the test results
研究组 & 干预措施
CD19-CAR-T2 T Cells
Experimental
The subject's T cells will be modified to those which could identify and kill the tumor cells (CD19+ cells). These CD19-CAR-T2 T cells will be infused over 10-15 minutes on days Day 1, 2 and 3 tentatively according to the response to infusion.
干预措施: CD19-CAR-T2 Cells (Biological)
结局指标
主要结局
The maximum tolerated dose(MTD) of CD19 positive relapsed/ refractory acute leukimia treated wtih CD19-CAR-T2 cells
时间窗: 24 weeks
次要结局
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment(12 months)
- Overall Response Rate(12 months)
研究者
研究点 (1)
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