A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measure the safety of ICAR19 CAR-T cells
研究概览
简要总结
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
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
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD19 positive leukemia and lymphoma，relapsed and/or refractory：
- •survival>12 weeks;
- •FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
- •LVEF≥50%;
- •Creatinine<2.5mg/dl;
- •Bilirubin<2.5mg/dl;
- •ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal;
- •At least 7 days after last chemotherapy;
- •provide with informed consent.
排除标准
- •Active clinically significant CNS dysfunction
- •Pregnant or breast-feeding women.
- •Uncontrolled active infection including hepatitis B or C.
- •HIV positive.
- •Use of systemic steroids within 72 hours.
- •Allogeneic lymphocyte treatments within recent 6 months.
- •Any uncontrolled active medical disorder.
研究组 & 干预措施
ICAR19 CAR-T cells
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells.
干预措施: ICAR19 CAR-T cells (Biological)
结局指标
主要结局
Measure the safety of ICAR19 CAR-T cells
时间窗: 2 years
To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
次要结局
- Measure the anti-tumor effect of ICAR19 CAR-T cells(3 years)
- Survival time of ICAR19 T cells in vivo.(5 years)
研究者
Xiulian Sun
Principal Investigator
Immune Cell, Inc.