NCT03281551Unknown1 期
Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Pinze Lifetechnology Co. Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Treatment Related Adverse Events
研究概览
简要总结
The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
- •In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology
- •In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:
- •Getting through 2 treatments of standard chemotherapy with CR not yet obtained
- •Reach CR for the first inducement, but CR lasts for ≦12 months
- •r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment
- •≧2 times of recurrence
- •Remedial chemotherapy is not used within 4 weeks before cell therapy
- •Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy
- •Antibody drug treatment is not received within 2 weeks before cell therapy
- •Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia
- •No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92%
- •No contraindications for leukapheresis
- •Expected survival >3 months
- •Grade 0 or 1 of ECOG performance status
排除标准
- •Pregnant and breastfeeding women
- •Uncontrolled active infection
- •Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E.
- •Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks
- •Stage II-IV Acute/chronic general graft versus host disease
- •Gene therapy has been undergone in the past
研究组 & 干预措施
PZ01 CAR-T Cells
Experimental
This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.
干预措施: PZ01 CAR-T cells (Drug)
结局指标
主要结局
Incidence of Treatment Related Adverse Events
时间窗: 1 year
To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma.
次要结局
- Overall response rate (ORR)(2 months)
- Overall survival (OS)(6 months)
- Minimal residual disease negative remission rate(MRD)(2 months)
研究者
研究点 (1)
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