NCT04771078Available不适用
Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
适应症
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- Celgene
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel.
Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.
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
- •Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
- •Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
- •Clinically stable
排除标准
- •Has a hypersensitivity to the active substance or to any of the excipients
- •No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
- •Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement
- •Other protocol-defined inclusion/exclusion criteria apply
研究者
相似试验
Available
不适用
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene CiloleucelLarge B-cell LymphomaFollicular LymphomaNCT05776160Kite, A Gilead Company
Available
不适用
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene AutoleucelAcute Lymphoblastic LeukemiaMantle Cell LymphomaNCT05776134Kite, A Gilead Company
Unknown
不适用
Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 SyndromePost COVID-19 SyndromeNCT04798066Hope Biosciences Research Foundation
Unknown
不适用
An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyneuropathyNCT04825626Hope Biosciences Research Foundation
终止
1 期
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid TumorsAdvanced Solid TumorsNCT04049617Gilead Sciences18