Early-stage Clinical Study of Mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- objective remission rate
研究概览
简要总结
Early-stage Clinical Study of mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed mesothelin-positive Ovarian Cancer
详细描述
This is a single-arm, open, dose-increasing, and extended early-stage clinical study of mesothin-specific chimeric antigen receptor T cells (LD013) in patients with mesothelin-positive drug-resistant relapsed ovarian cancer. This study included two phases: dose escalation and extension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fully understand and voluntarily sign informed consent.
- •Aged at least 18 years old，female.
- •Expected survival > 12weeks.
- •Eastern Cooperative Oncology Group (ECOG) score 0or
- •Staining of mesothelin must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. Tissue obtained for the biopsy must be ≤2year prior to enrollment for screening, not have been previously irradiated or exposed to chemotherapy. If unavailable, new tissue material from a recently obtained surgical or diagnostic biopsy is mandatory for this trial；
排除标准
- •Prior treatment with any CART therapy targeting any target.
- •Subjects with severe mental disorders.
- •Subjects with other malignant tumors.
- •Patient is positive for Syphilis, Human Immunodeficiency Virus (HIV) , active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected).
- •Detectable clinically relevant central nervous system (CNS) metastases and/or pathology such as epilepsy/seizure, brain Ischemia/ hemorrhage, dementia, cerebellar disease, or autoimmune disease affecting central nervous system；
- •Patients with ongoing or active infection.
- •Subjects not appropriate to participate in this clinical study judged by investigators.
研究组 & 干预措施
Single-arm open clinical study
After blood collection from qualified subjects, lymphocytes will be pretreated，the subjects will then be treated with CAR T cells.
干预措施: mesothelin-specific chimeric antigen receptor T cell injection (Drug)
结局指标
主要结局
objective remission rate
时间窗: 4-6weeks
objective remission rate
次要结局
未报告次要终点
研究者
Weijia Fang, MD
chief physician
Zhejiang University