NCT05776160Available不适用
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 249
研究概览
简要总结
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
- •Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
- •Deemed medically fit and stable to receive the product per the investigator's evaluation
- •Repeat leukapheresis is not feasible per the investigator's assessment
- •Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
- •In the investigator's opinion, there is no satisfactory alternative therapy available to the individual
排除标准
- •History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
- •Uncontrolled active infection or inflammation per physician assessment
- •Primary central nervous system lymphoma
研究者
研究点 (249)
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