临床试验/NCT02390297

NCT02390297进行中（未招募）不适用

Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct

Calimmune, Inc.2 个研究点分布在 1 个国家目标入组 11 人开始时间: 2015年4月1日最近更新: 2025年10月10日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Calimmune, Inc.
入组人数: 11
试验地点: 2
主要终点: Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Long term safety follow-up of Cal-1 recipients

详细描述

Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct

研究设计

研究类型: Observational
观察模型: Other
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Signed informed consent
•Previous treatment with the Cal-1 modified hematopoietic cellular products

排除标准

•Inability to understand and provide informed consent

结局指标

主要结局

Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures

时间窗: 15 years

次要结局

Assessment of the long term survival and activity of Cal-1 modified hematopoietic cells through evaluation of Cal-1 marking and expression in peripheral blood(15 yars)

研究者

发起方

Calimmune, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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