CD19-STAR-T for Patients With B Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of adverse events
研究概览
简要总结
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies (such as NHL and ALL ).
详细描述
This Phase I study is designed as a pilot trial evaluating the safety and of CD19-STAR-T cell therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19-STAR-T cells. Safety and efficacy of CD19-STAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19-STAR-T cells therapy in patients with refractory and relapsed B-cell malignancies.
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
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed and refractory CD19 positive B-cell acute malignancies with:
- •Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
- •MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
- •Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
- •Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
- •Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
- •Ages 1 to 70 years, including boundary values;
- •ECOG score 0-3 points;
- •Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
排除标准
- •patients with organ failure:
- •Heart: NYHA heart function grade III or IV ;
- •Liver: Grade C that achieves Child-Turcotte liver function grading;
- •Kidney: kidney failure and uremia;
- •Lung: symptoms of respiratory failure;
- •Brain: a person with a disability;
- •Active infections that are difficult to control;
- •Human immunodeficiency virus (HIV) positive;
- •Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
- •GVHD ≥ 2 or receiving anti-GVHD treatment;
- •Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion(DLI);
- •Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
- •Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count >15WBCs/mL);
- •intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
- •pregnant or lactating women;
- •The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
- •Patients who participate in other clinical studies at the same time;
- •The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
结局指标
主要结局
Percentage of adverse events
时间窗: 6 months
Percentage of participants with adverse events.
Objective Remission Rate(ORR)
时间窗: 6 months
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
次要结局
- Relapse-Free Survival(RFS )(6 months)
- Overall-Survival(OS)(6 months)
- Persistence of STAR-T cells in vivo(6 months)