The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percentage of participants with 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/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .
详细描述
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.The purpose of current study is to evaluate the clinical safety and efficacy of CD19/CD22-Dual-STAR-T cells therapy in patients with refractory and relapsed B-ALL.Safety and efficacy of Dual-STAR-T cells therapy will be monitored. The primary endpoint is the safety of Dual-STAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the Dual-STAR-T cell proliferation ratio and Dual-STAR gene copied number in peripheral blood（PB）， and progression free survival(PFS ), overall-survival(OS) and duration of overall response(DOR).
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
- •Ages 1 to 70 years.
- •Prelapsed and refractorys B-ALL at least with one of the following conditions:
- •Could not achieve CR after 2course of chemotherapy.
- •Could not achieve CR or relapse after first-line or multi-line salvage chemotherapy, or MRD≥0.1%.
- •Relapse within 12 months after first remission or MRD≥0.1%.
- •Relapse after achieved CR in allogeneic hematopoietic stem cell transplantation (HSCT), or MRD≥0.1%.
- •For Ph + patients: Failure to tolerate TKI or TKI treatment failure could be enrolled.
- •CD19 and/or CD22 positive within 3 months.
- •Estimated life expectancy ≥ 3 months.
- •Women of childbearing age 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 12 months after discontinuation of treatment during the study period not pregnant inside.
- •Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
排除标准
- •Active infections that are difficult to control
- •HBV-DNA HCV-RNA and HIV ,either of which is positive
- •Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy
- •Patients are receiving anti-GVHD treatment within 4 weeks of before screening.
- •Performed major surgery within 4 weeks before screening.
- •Patients have received chemotherapy within 7 days of screening.
- •Experimental drugs were used within 4 weeks before screening.
- •Received allogeneic cell therapy within 6 weeks prior to cell infusion.
- •Patients have history of epilepsy or central nervous system diseases.
- •Severe thyroid dysfunction
- •Patients with active autoimmune disease.
- •Pregnant or lactating women.
- •The patient does not agree to use effective contraception during treatment and for the following 12 months;
- •The researchers found that it was unsuitable for the recipients to be enrolled.
结局指标
主要结局
Percentage of participants with adverse events.
时间窗: 12 months
Percentage of participants with adverse events.
次要结局
- Objective Remission Rate(ORR)(12 months)
- Proliferation ratio of Dual-STAR-T cells(12 months)