Phase II Study of Autologous Murine Anti-CD19 Chimeric Antigen Receptor T Cells Treating Refractory or Relapsed B Acute Lymphoblastic Leukemia Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- CR rate
研究概览
简要总结
The investigators will conduct a phase II clinical trial of autologous murine anti-CD19 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia children in Beijing Boren Hospital. The study will be approved by the institutional review board of Beijing Boren Hospital, and informed consent will be obtained in accordance with the Declaration of Helsinki. All these participants will be matched the diagnostic criteria for (r/r) B-ALL according to the WHO classification and complete morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis and leukemia fusion gene screening by multiplex nested reverse transcriptase-polymerase chain reaction (PCR). Participants will be eligible if they are heavily treated B-ALL who failed from re-induction chemotherapy after relapse or continued MRD+ for more than three months, and had positive CD19 expression on leukemia blasts by FCM (>95% CD19). After CAR T-cell infusion, clinical outcomes including overall survival (OS), Disease-free survival (DFS), adverse effects and relapse will be evaluated.
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
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference. Extramedullary diseases (EMDs) were confirmed CD19+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography. The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD19 expression on leukemia blasts by FCM (>95% CD19 positive);
- •Age from 0 to 18 years old;
- •Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form;
排除标准
- •Intracranial hypertension or unconscious;
- •Acute heart failure or severe arrhythmia;
- •Acute respiratory failure;
- •Other types of malignant tumors;
- •Diffuse intravascular coagulation;
- •Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range;
- •Sepsis or other uncontrolled infection;
- •Uncontrolled diabetes mellitus;
- •Severe psychological disorder;
- •Obvious cranial lesions with cranial MRI;
- •More than 20 counts/ul leukemic cells in cerebrospinal fluid;
- •More than 30% leukemic cells in the blood;
- •Stage III WHO/ECOG score;
- •Organ recipients;
- •Pregnant or breastfeeding;
- •Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
研究组 & 干预措施
Autologous Murine Anti-CD19 CAR-T treatment
干预措施: Murine autologous anti-CD19 chimeric antigen receptor T cells (Biological)
结局指标
主要结局
CR rate
时间窗: 1 month
The complete remission(CR) rate to the CAR-T treatment
次要结局
未报告次要终点