Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor(CAR) T Cells Against Relapsed and Refractory B-cell Lymphoma
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
- Overall complete remission rate
研究概览
简要总结
Cluster of differentiation antigen 19(CD19) specifically presents in B lymphocyte cell lines steadily,while not in most normal tissue,including pluripotent hematopoietic stem cells.Cluster of differentiation antigen 20(CD20) presents in 90% of B-cell lymphomas.CD19 antigen is a well-established target for B-cell lymphomas treatment as well as CD20 antigen.Both CD19-targeting CAR T Cells and CD20-targeting CAR T Cells can be used as adoptive cellular immunotherapies for B-cell lymphomas.Though two kinds of single target treatments were proved can induce recession of B-cell lymphomas, the risk of cancer cells to escape and tumor recurrence are still existed. There are no report about combination transfer of two kinds of single target treatments.This research aimed emphasis on safety and therapeutic efficacy evaluation,as well as if combination transfer can decrease recurrence rate.
详细描述
To determine:
Primary Outcome Measure:
The Overall complete remission rate and one-year survival rate of combination transfer of CD19-targeting CAR T Cells and CD20-targeting CAR T Cells is superior to or at least not worse than two kinds of single target treatments in the treatment of CD19+/CD20+ B-cell lymphomas.
The risk of cancer recurrence in a year of combination transfer of CD19-targeting CAR T Cells and CD20-targeting CAR T Cells is inferior to two kinds of single target treatments.
Secondary Outcome Measures:
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 Years to 70 Years, Male and female
- •Survival time>12 weeks
- •B cell lymphomas diagnosed by Physical examination,pathological examination,Laboratory tests and imaging tests
- •Chemotherapy failure or recurrent B cell lymphomas
- •Creatinine< 2.5mg/dl
- •Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
- •Bilirubin<2.0mg/dl
- •Karnofsky Performance Status>50% at the time of screening
- •Adequate pulmonary, renal, hepatic, and cardiac function
- •Fail in autologous or allogenic haemopoietic stem cell transplantation
- •Free of leukocytes removal contraindications
- •Voluntarily join CAR-T clinical trial
- •Understand and sign written informed consent
排除标准
- •Pregnant or nursing women or women with pregnancy plan in half a year
- •Any infectious disease (HIV, active tuberculosis, ect.)
- •Active hepatitis B, active hepatitis C infection
- •Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte amplification is below 5 fold with the costimulation of cluster of differentiation 3(CD 3)and cluster of differentiation 8(CD 8)
- •Abnormal vital signs or cannot cooperate with the inspectors
- •mental or psychological disease cannot cooperate with treatment and curative effect evaluation
- •Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2(IL-2)
- •General infection or local severe infection, or other infection that is not controlled
- •Dysfunction in lung, heart, kidney and brain
- •Severe autoimmune diseases
- •Other symptoms that are not applicable for CAR-T
结局指标
主要结局
Overall complete remission rate
时间窗: Half a year
The complete remission rate will be evaluated by routine methods.
次要结局
- The initial effect time(1 year)
- The one-year survival rate(1 year)
- The safety and the tolerability(incidence of treatment-emergent adverse events defined as dose-limited toxicity)(1 month)
- The life quality improvement(1 year)
- The time to disease progression(1 year)
- The one-year recurrence(1 year)