CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occurrence of related adverse events
研究概览
简要总结
Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).
详细描述
When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.
Extra blood will be drawn to measure the persistence of CART30 in vivo.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
- •Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
- •Karnofsky or Lansky score greater than 60%.
- •Expected survival>12 weeks.
- •Creatinine<2.5mg/dl.
- •ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal.
- •Bilirubin<2.5mg/dl.
- •Pulse oximetry of >90% on room air.
- •Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
- •Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
- •Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
排除标准
- •Active infection such as hepatitis B or C.
- •Receive anti-CD30 antibody-based therapy within recent 6 weeks.
- •Current use of systemic corticosteroids.
- •Pregnant or lactating.
- •Confirmed tumor in pulmonary and archenteric tissues.
结局指标
主要结局
Occurrence of related adverse events
时间窗: untill week 24
次要结局
- Anti-tumor response to CART30 cell infusions(Up to 24 weeks)
研究者
Han weidong
Director
Chinese PLA General Hospital