Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)
详细描述
The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)
- •Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
排除标准
- •Previous treatment with investigational gene or cell therapy medicine products
- •CD19 negative B-cell leukemia
- •Any uncontrolled active medical disorder that would preclude participation as outlined
研究组 & 干预措施
allogeneic CART-19
infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
干预措施: allogeneic CART-19 (Biological)
结局指标
主要结局
Occurrence of study related adverse events
时间窗: 1 year
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria
次要结局
- Overall response rate of allogeneic CART-19(up to 24 weeks)
- Overall survival(up to 24 weeks)
- Disease-free survival(up to 24 weeks)