A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
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 ICAR30 T cells
研究概览
简要总结
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.
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
盲法说明
None (Open Label)
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
- •Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:
- •Karnofsky or Lansky score >50;
- •Expected survival>12 weeks;
- •Hgb > 8.0;
- •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 fold normal;
- •Patients must sign an informed consent.
排除标准
- •Pregnant or lactating;
- •Uncontrolled active infection including hepatitis B or C;
- •HIV positive;
- •Active clinically significant CNS dysfunction;
- •Current use of systemic steroids;
- •Heterogenous lymphocyte treatments within recent 6 months;
研究组 & 干预措施
ICAR30 T cells
anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.
干预措施: ICAR30 T cells (Biological)
结局指标
主要结局
Measure the safety of ICAR30 T cells
时间窗: 2 years
To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
次要结局
- Measure the anti-tumor effect of ICAR30 T cells(3 years)
- Measure the survival time of ICAR30 T cells in vivo(5 years)
研究者
Xiulian Sun
Principal Investigator
Immune Cell, Inc.