NCT02963038Unknown1 期
Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy
Hebei Senlang Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tumor load
研究概览
简要总结
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.
详细描述
The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
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
- •The treat history meeting the following criteria:
- •Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
- •Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
- •One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
- •There is a measurable lesions before treatment at least;
- •ECOG score≤2;
- •To be aged 1 to 70 years;
- •More than a month lifetime from the consent signing date
排除标准
- •Serious cardiac insufficiency, left ventricular ejection fraction<50;
- •Has a history of severe pulmonary function damaging;
- •Merging other malignant tumor;
- •Merging uncontrolled infection;
- •Merging the metabolic diseases (except diabetes);
- •Merging severe autoimmune diseases or immunodeficiency disease;
- •patients with active hepatitis B or hepatitis C;
- •patients with HIV infection;
- •Has a history of serious allergies on Biological products (including antibiotics);
- •Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
结局指标
主要结局
Tumor load
时间窗: Up to 24 months
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
次要结局
- CAR T cell persistence(Up to 24 months)
研究者
研究点 (1)
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