jRCT2013210008已完成不适用
A phase3b study of KTE-C19 (at the time of manufacture of commercially available products) in patients with the indication on the package insert
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •Patients who have been identified and manufactured to meet the requirements for treatment with commercially available axicabtagene ciloleucel. The product does not conform to the commercial product specification and cannot be shipped as a commercial product. However, the product conforms to the clinical trial product specification and the sponsor determines that the product can be diverted to the clinical trial product.
- •Patients for whom the principal investigator or the subinvestigator has assessed the patient's condition and disease, and determined that they cannot wait for remanufacturing of the product that meets the commercially available specifications from the re-leukocyte apheresis or from the excess PBMC frozen at the manufacturing site.
排除标准
- •Patients for whom the principal investigator or the subinvestigator judged that participation in the clinical trial was inappropriate.
结局指标
主要结局
-
To evaluate safety of non-standard commercial products based on adverse events.
次要结局
- objective response rate (ORR)
- overall survival (OS)
- pharmacokinetics in vivo of KTE-C19
研究者
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