Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- occurrence of study related adverse events
研究概览
简要总结
Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells
详细描述
CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.
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
- 4 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •expected lifespan >3 months
- •patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
- •for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
- •enough function of heart, liver, kidney and bone marrow
- •no history of severy allergy
- •no other serious diseases that conflict with this plan
- •no other history of malignancy
- •no serious mental illness
- •patients and their families members agree to participate in this clinical study and sign the Informed Consent Form
排除标准
- •pregnant or lactating women
- •vevere infectious or viral diseases
- •active hepatitis B or C viral hepatitis
- •Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
- •participated in other clinical studies in the past 3 months or who have been treated with other gene products;
- •others that other investigators consider not suitable for this clinical study
研究组 & 干预措施
experimental arm
cord blood derived CAR T cells group
干预措施: CAR-T cells (Biological)
结局指标
主要结局
occurrence of study related adverse events
时间窗: one year
safety of CAR-T cells
次要结局
- objective response rate(three months)
- progression-free survival(one year)
- overall survival(one year)
- copy number of CAR-T(six months)