NCT03110640Unknown1 期
A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma
First Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety - incidence of adverse events defined as dose-limited toxicity
研究概览
简要总结
This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
详细描述
Primary objectives
- To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives
- To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation
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
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 Years to 70 Years, Male and female;
- •Expected survival > 12 weeks;
- •Performance score 0-2;
- •Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
- •Creatinine < 2.5 mg/dl;
- •ALT/AST < 3x normal;
- •Bilirubin < 2.0 mg/dl;
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis;
- •Take contraceptive measures before recruit to this trial;
- •Written voluntary informed consent is given.
排除标准
- •Patients with symptoms of central nervous system
- •Accompanied by other malignant tumor
- •Active hepatitis B or C, HIV infection
- •Any other diseases could affect the outcome of this trial
- •Suffering severe cardiovascular or respiratory disease
- •Poorly controlled hypertension
- •A history of mental illness and poorly controlled
- •Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
- •Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
- •Reaching a steady dose if receiving anticoagulant therapy before assignment
- •Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- •Pregnant or lactating women
- •Subject suffering disease affects the understanding of informed consent or comply with study protocol.
研究组 & 干预措施
CD9CAR-T transfer
Experimental
All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
干预措施: anti-CD19 CAR-T (Biological)
CD9CAR-T transfer
Experimental
All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
干预措施: Fludarabine (Drug)
CD9CAR-T transfer
Experimental
All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Safety - incidence of adverse events defined as dose-limited toxicity
时间窗: 180 days
incidence of adverse events defined as dose-limited toxicity
次要结局
- Duration of remission(1 year)
- Overall complete remission rate(1 year)
研究者
Kang YU
Principal Investigator
First Affiliated Hospital of Wenzhou Medical University
研究点 (1)
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