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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 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.
研究组 & 干预措施
CART19
Experimental
CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.
干预措施: CART 19 (Biological)
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 (1)
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