NCT04788472已完成2 期
Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients with Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年3月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Complete molecular response (CMR) rate
研究概览
简要总结
Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
详细描述
This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
- •Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
- •Leukemia cells were CD19 and CD22 positive;
- •Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
- •Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;
- •Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;
- •Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;
- •The prognosis for survival is more than 3 months;
- •ECOG score 0-2;
- •Subjects volunteered to participate in this trial and signed an informed consent form.
排除标准
- •Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial:
- •Those with a history of epilepsy or other central nervous system disorders;
- •Those with a history of prolonged QT period or severe cardiac disease;
- •Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
- •Those with uncontrolled active infection;
- •Active hepatitis B or hepatitis C virus infection;
- •Those who have previously used any gene therapy product;
- •Those with insufficient amplification (<5-fold) in response to CD3/CD28 co-stimulatory signals;
- •Creatinine > 2.5 mg/dl or ALT / AST > 3 times the upper limit of the normal range or bilirubin > 2.0 mg/dl;
- •Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;
- •HIV-infected persons;
- •Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.
研究组 & 干预措施
CAR-T therapy
Experimental
Administration of CD19 and CD22 CAR T-cells
干预措施: CAR-T cells targeting CD19 and CD22 (Drug)
结局指标
主要结局
Complete molecular response (CMR) rate
时间窗: Up to 1 month after CAR-T cells infusion
Complete molecular response (CMR) rate after CD19 CAR-T cell therapy
次要结局
- Complete molecular response (CMR) rate(Up to 1 month after CAR-T cells infusion)
- Leukemia-free survival (LFS)(Up to 2 years after CD19 CAR-T cells infusion)
- Overall survival (OS)(Up to 2 years after CD19 CAR-T cells infusion)
- cumulative incidence of relapse (CIR)(Up to 2 years after CD19 CAR-T cells infusion)
- Incidence of treatment-emergent adverse events (TEAEs)(Through study completion, an average of 2 years)
- Characterization of relapse(Through study completion, an average of 2 years)
研究者
He Huang
Professor
Zhejiang University
研究点 (1)
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