Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 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 CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
详细描述
CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.
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
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •expected lifetime>3 months
- •CD19/CD20 positive relapsed/refractory B cell lymphoma
- •at least one measurable lesion according to RECIST 1.1
- •enough function of hear, liver, kidney and bone marrow
- •no history of severe allergies
- •no other history of malignancy
- •no other diseases that conflict with this regimen
- •no serious mental illness
- •patient or family member sign informed consent
排除标准
- •Pregnant or lactating women
- •Severe infectious or viral disease
- •Active B or C viral hepatitis
- •Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
- •participated in other clinical studies in the last 3 months, or have been treated with other gene products
- •Others not appropriate to participate in this study examined by the investigators
研究组 & 干预措施
experimental arm
CAR-T cell group
干预措施: CD19/CD20 bispecific 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
- progression-free survival(one year)
- objective response rate(three months)
- survival time of CAR-T cells in vivo(one year)