Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall responce rate(ORR)
研究概览
简要总结
This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
详细描述
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ，and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment < 2 years, The specific requirements are as follows:
- •Male or female aged 18-70 years old ;
- •Estimated Survival time > 12 weeks;
- •Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging;
- •Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas;
- •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;
- •Not suitable for stem cell transplantation conditions or abandoned due to conditions;
- •Free of leukocytes removal contraindications;
- •Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent.
排除标准
- •The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
- •Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
- •The patient is an active hepatitis B or hepatitis C infection;
- •Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
- •Abnormal vital signs;
- •Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;
- •Highly allergic constitution or history of severe allergies, especially allergy to interleukin-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 responce rate(ORR)
时间窗: 2 years
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Overall survival (OS)
时间窗: 2 years
Assessment of OS(Overall survival) at 6 months of treatment
Progression-free survival (PFS)
时间窗: 2 years
Assessment of PFS(Progression-free survival ) at 6 months of treatment
minimal residual disease（MRD）
时间窗: 2 years
Assessment of MRD negative overall response rate at 3 months of treatment
次要结局
- Safety (incidence of adverse events defined as dose-limited toxicity)(Study treatment until Week 24)
- Expression of CD19 CART cells(2 years)
- Detection of CD19 CART cells(2 years)
研究者
LiFei
M.D.,Ph.D.
The First Affiliated Hospital of Nanchang University