NCT02935543终止2 期
Phase 2 Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) for Adult Patients With Minimal Residual Disease During Upfront Treatment for Acute Lymphoblastic Leukemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01%
研究概览
简要总结
This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.
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
- •Patients with CD19+, B cell Acute Lymphoblastic Leukemia (B-ALL) who have 0.01%≤MRD<10% during upfront treatment
- •Patients must be within 18 months of initial ALL diagnosis
- •Age ≥18 years
- •Adequate organ function defined as:
- •Creatinine ≤ grade 2
- •ALT/AST ≤3x upper limit of normal range for age
- •Direct bilirubin ≤2.0 mg/dl
- •Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia
- •Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
- •Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy.
- •Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood
- •Adequate performance status defined as ECOG Performance Status 0 or 1
- •Provides written informed consent
- •Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol
排除标准
- •Active, uncontrolled infection
- •Active hepatitis B or hepatitis C
- •HIV Infection
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 2)
- •Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment.
- •Pregnant or nursing (lactating) women
- •Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
结局指标
主要结局
The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01%
时间窗: Day 28
The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment
次要结局
- Percentage of Manufacturing Products That do Not Meet Release Criteria for Vector Transduction Efficiency, T Cell Product Purity, Viability, Sterility or Due to Tumor Contamination.(prior to day 1)
- Relapse Free Survival (RFS)(one year)
- Safety and Tolerability of CART19: Frequency and Severity of Adverse Events, Including, But Not Limited to, Cytokine Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS).(one year)
- Best Overall Survival (OS)(one year)
- Duration of Remission (DOR)(one year)
- Event Free Survival (EFS)(one year)
研究者
研究点 (2)
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