NCT02842138Unknown1 期
A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting CD19 in Patients With Relapsed or Refractory B-cell Lymphoma
Peking University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
This is a single arm, open-label, one center, dose escalation clinical study to determine the safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive B-cell lymphoma.
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
- •CD19+ B cell lymphoma,verified by IHC or flow cytometry.
- •a prior history of at least two standard care of medication.
- •ineligible for allogeneic transplantation or relapsed after transplantation.
- •patients are 18 years older.
- •life expectancy > 3months.
- •satisfactory major organ functions: adequate heart function with LVEF≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
- •Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L.
- •women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
- •measurable tumors.
排除标准
- •using immunosuppressive drugs or systemic steroids within one week of enrollment.
- •active infection.
- •HIV positive.
- •active hepatitis B virus infection or hepatitis C virus infection.
- •breastfeeding or pregnant women.
- •patients refuse to practice birth control during study and one year post study.
- •patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study.
- •currently enrolled in other study.
- •patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
研究组 & 干预措施
CD19 CAR T cells
Experimental
A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.
干预措施: autologous anti-CD19 CAR T cells (Biological)
结局指标
主要结局
Number of patients with adverse events
时间窗: 2 years
次要结局
- overall survival rate of patients treated with anti-CD19 CAR T cells(2 years)
- progression-free survival of patients treated with anti-CD19 CAR T cells(2 years)
- Treatment response rate of anti-CD19 CAR T cell infusion(4 weeks)
研究者
Jun Zhu
Principal Investigator
Peking University
研究点 (2)
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