Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The adverse events associated with CAR T cell product infusions are assessed.
研究概览
简要总结
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies
- •Absolute lymphocyte count, ALC )≧600/μl
- •HIV, HTLV, Syphilis negative
- •GPT ≦200 U/L
- •Cr ≦221 umol/L
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis.
- •Voluntary informed consent is given.
排除标准
- •Body weight < 20Kg
- •Pregnant women.
- •Uncontrolled active infection.
- •Active hepatitis B or hepatitis C infection.
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- •Previously treatment with any gene or cell therapy products.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •Expected survival< 12 weeks
- •Received investigational drug or device within 30 days pre-trial;
- •Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.
研究组 & 干预措施
Welgenaleucel (UWC19)
The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times
干预措施: Welgenaleucel (Genetic)
结局指标
主要结局
The adverse events associated with CAR T cell product infusions are assessed.
时间窗: 30 days
The type, frequency, severity, and duration of adverse events will be summarized
次要结局
未报告次要终点