A Pilot Study of CMV-TCR-T Cells in CM Virus Infection Diseases After HSCT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 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 cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.
详细描述
CMV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic CMV-TCR-T cell therapy in subjects with CMV infection, patients with CMV emias or deseases will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-70 years, including boundary values, gender unlimited;
- •Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia;
- •At least one of the following conditions after allogeneic HSCT:
- •After trested with 2-week standard antiviral drug, compared to the baseline of treatment, the decrease of CMV DNA copies number was less than 1log10, and the CMV DNA copies number is greater than 1000 copies/ mL ;
- •Unable to tolerate the toxic and side effects of antiviral drugs,such as bone marrow hematopoietic suppression, nephrotoxicity;
- •Estimated life expectancy ≥3 months；
- •Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
排除标准
- •Patients with active aGVHD III-IV and / or mild and severe cGVHD;
- •Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
- •Pregnant or lactating women;
- •Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;
- •patients with organ failure:
- •Heart: NYHA heart function grade IV;
- •Liver: Grade C that achieves Child-Turcotte liver function grading;
- •Kidney: kidney failure and uremia;
- •Lung: symptoms of respiratory failure;
- •Brain: a person with a disability;
- •The researchers found that it was unsuitable for the recipients to be enrolled.
结局指标
主要结局
Percentage of adverse events
时间窗: 3months
Percentage of participants with adverse events.
次要结局
- Persistence of TCR-T cells(3months)
- Changes of CMV-DNA copies number(3months)