Open, Single Arm,Multicenter Phase 2 Clinical Study to Evaluating the Efficacy and Safety of the Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) for CD19 Positive Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy.
研究概览
简要总结
This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the CD19 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.
详细描述
This is an open, single-arm,multicenter 2 phase clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of CD19 positive lymphoma. The study will be conducted using a phaseⅠ/Ⅱdesign the study will have the following sequential phases: part A (screening, leukapheresis, cell product preparation and cytoreductive chemotherapy) and part B (treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion. The total duration of the study are expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age older than 16 years old,gender and race no limited.
- •2.Pathological diagnosis of CD19 express positive recurrent or refractory B lymphoma, satisfy any of the following a diagnosis of recurrent or refractory lymphoma: (1) According to the standard solution standardization more than four courses of treatment, tumor size < 50% or progression;(2) According to the standard solution treatment of complete remission, after recurrence again with the original plan or the national expert consensus recommended second-line cannot again get to complete remission (3) Relapse after hematopoietic stem cell transplantation.
- •3.Patients into the group needs lesions to be available for testing or evaluating disease.
- •4.ECOG score reaches 0 to 1 points.
- •5.Patients into the group of White Blood Cell counts in peripheral blood acuity≥ 1.0 x10^9 / L.
- •6.Estimated survival times > 90 days.
- •7.Patients have self-knowledge ability, can sign the informed consent form.
排除标准
- •1.Pregnant or lactating women.
- •2.Uncontrolled infection.
- •3.HIV infection, hepatitis B or C activity period.
- •4.Patients who need long-term immunosuppressive therapy (Such as allergies, autoimmune diseases, GVHD, etc.)
- •5.Combined activity of the central nervous system malignant tumor invasion.
- •6.Abnormal coagulation function, patients with severe thrombosis.
- •Organ failure Heart：class Ⅱ or above. Liver：class Ⅱ or above( Refer to Classification of Wuhan Conference (1983)). Kidney: The second stage of renal insufficiency or above. Lung: class Ⅱdecreased slightly or above. Brain: The central nervous system transfer or have active lesions.
- •8.Patients who have participated in other clinical trials in the past 30 days or or participate in other clinical trials at the same time.
- •9.Investigator believe that the patient is not suitable to participate in the study.
结局指标
主要结局
The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy.
时间窗: up to 90 days
The objective reaction rate will be determined by the evaluation of CT/PET-CT.Evaluation of the objective reaction rate according to the non-hodgkin's lymphoma curative effect evaluation criteria of international lymphoma group. The objective reaction rate = (complete remission (CR) number + partial remission (PR) number / total number of cases receiving treatment.
次要结局
- 3°or above incidence rate of serious adverse reaction related to treatment(3years)
- Progression free survival time(3years)
- Overall survival time(3years)
- Patients - -based Quality of Life Evaluation(3years)