Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
研究概览
简要总结
The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.
详细描述
Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry
- •Refractory or relapsed B cell-acute lymphoblastic leukemia
- •No available curative treatment options (such as hematopoietic stem cell transplantation)
- •Stage III-IV disease
- •Creatinine < 2.5 mg/dl
- •Aspartate transaminase-alanine transaminase ratio < 3x normal
- •Bilirubin < 2.0 mg/dl
- •Karnofsky performance status >= 60
- •Expected survival time > 3 months
- •Adequate venous access for apheresis
- •Ability to understand and provide informed consent
排除标准
- •Pregnant or lactating women
- •Patients requiring T cell immunosuppressive therapy
- •Active central nervous system leukemia
- •Any concurrent active malignancies
- •Patients with a history of a seizure disorder or cardiac disorder
- •Previous treatment with any immunotherapy products
- •Patients with human immunodeficiency virus, hepatitis B or C infection
- •Uncontrolled active infection
结局指标
主要结局
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
时间窗: 2 years
次要结局
- CART cells persistence in vivo(2 years)
- Overall Complete Remission Rate (ORR)(2 years)
- Disease response(CR, CRi)(2 years)