NCT07252336招募中2 期
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月30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
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complete Molecular Response Rate after CD19 CAR-T Cell Therapy
研究概览
简要总结
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
详细描述
This study is a single-arm, open-label, multicenter clinical trial that plans to enroll approximately 50 adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia to undergo CD19 CAR-T cell therapy. The primary objective is to evaluate the efficacy of CD19 CAR-T therapy in adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia. The secondary objective is to assess the safety of CD19 CAR-T therapy in this patient population. The exploratory objectives include evaluating the in vivo expansion and persistence of CAR-T cells, as well as B-cell depletion.
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, gender not restricted;
- •Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
- •Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
- •Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
- •Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
- •Serum total bilirubin ≤ 51 μmol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol/L;
- •Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;
- •Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status score 0-2;
- •Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;
- •Subjects voluntarily participate in this study and sign the informed consent form.
排除标准
- •Subjects meeting any of the following exclusion criteria are ineligible for enrollment in this study:
- •Subjects with a history of epilepsy or other central nervous system diseases;
- •Subjects with a prior history of QT interval prolongation or severe cardiac diseases;
- •Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- •Subjects with untreated active infections;
- •Subjects with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; subjects with serological evidence of hepatitis C virus (HCV) infection who have not completed curative treatment or have a detectable HCV viral load;
- •Human immunodeficiency virus (HIV) antibody positive;
- •Syphilis antibody positive;
- •Subjects who have previously received any gene therapy products;
- •Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;
- •Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.
研究组 & 干预措施
CAR-T cells（ chimeric antigen receptor T cells）
Experimental
CD19 CAR-T 2×10e6 CAR+ T cells/kg,
干预措施: CD19 CAR-T cells (Drug)
结局指标
主要结局
Complete Molecular Response Rate after CD19 CAR-T Cell Therapy
时间窗: 28 days after infusion
Laboratory tests
次要结局
- Leukemia-Free Survival(2 years after infusion)
- Overall survival(2 years after infusion)
- Cumulative Incidence of Relapse(2 years after infusion)
- Complete Molecular Response Rate after CD22 CAR-T Cell Therapy(2 years after infusion)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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