NCT03064269招募中1 期
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3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
- The complete remission (CR) rate
研究概览
简要总结
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.
详细描述
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
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
盲法说明
Open Label
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
- •ALT/ AST 《 3x normal
- •Creatinine 《 3x normal
- •Signed informed consent
排除标准
- •Active hepatitis B , hepatitis C or HIV infection
- •Uncontrolled active infection
- •Pregnancy or breast-feeding women
- •Survival less than four weeks
结局指标
主要结局
The complete remission (CR) rate
时间窗: Participants will be followed for the duration of the treatment, an expected average of 12 months
The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory SchizophreniaSchizophreniaNCT05282329Tianjin Anding Hospital50
招募中
不适用
Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness (DeliTACS)DeliriumNCT06460363Kuopio University Hospital78
已完成
不适用
Effects of Gamma-tACS on Memory and SleepTranscranial Alternating Current StimulationAgingCognitive DeclineMemorySleepNCT05907707University of North Carolina, Chapel Hill11
招募中
不适用
tACS for Neuropathic Pain Management After SCINeuropathic Pain ManagementNCT06029075The University of Texas Health Science Center, Houston14
招募中
不适用
tACS for Sensory Motor Recovery After StrokeMotor RecoveryNCT06029062The University of Texas Health Science Center, Houston14