CD19-directed Chimeric Antigen Receptor T Cells Therapy in Relapsed/Refractory B Cell Malignancy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
详细描述
Tongji Hospital of Tongji University has developed an investigational approach for treating patients with CD19 positive B cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack CD19 positive cells, and then giving the cells back to the patients.The main purpose of the study is to assess the safety and efficacy of the treatment with anti-CD19 CAR-T cells in the patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and 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
- 6 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD19+ leukemia or lymphoma, meeting the following criteria:
- •At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
- •Less than 1 year between last chemotherapy and progression
- •Not eligible or appropriate for allo-HSCT
- •To be aged 6 to 85 years
- •Estimated survival of ≥ 6 months, but ≤ 2 years
- •ECOG score ≤2
- •Relapse after auto-HSCT
- •Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time
- •Voluntary participation in the clinical trials and sign the informed consent
排除标准
- •History of epilepsy or other CNS disease
- •Patients have GVHD, which needs treatment with immunosuppressive agents
- •Patients with prolonged QT interval or severe heart disease
- •Patients in pregnancy or breast-feeding period
- •Uncontrolled active infection
- •Active hepatitis B or hepatitis C infection
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
- •Previously treatment with any gene therapy products
- •Feasibility assessment during screening demonstrates <20% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
- •ALT /AST>3 x normal value; Creatinine> 2.5 mg/dl; Bilirubin >2.0 mg/dl
- •Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
- •HIV infection
- •Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation
研究组 & 干预措施
CAR-T cells
Autologous 2nd generation CD19-directed CAR-T cells
干预措施: CD19-directed CAR-T cells (Biological)
结局指标
主要结局
Occurrence of study related adverse events
时间窗: 2 years
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly，likely，or definitely related to the study.
次要结局
- Response rates to CAR-T cells(2 years)
- Overall survival(OS) of patients treated with CAR-T cells(2 years)
- Progression free survival(PFS)(2 years)
- Duration of remission(DOR)(2 years)
研究者
Aibin Liang，MD，Ph.D.
Director，Department of Hematology
Shanghai Tongji Hospital, Tongji University School of Medicine