GD2 CAR T MANUFACTURING

GD2 车制造

• 批准号: 10045915
• 负责人: GEORGE MITRA
• 金额: $ 469.68万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045915
• 关键词: Childhood Solid Neoplasm; Clinical; Development; Multi-Institutional Clinical Trial; Preparation; Process; Production; Resources; assay development; base; design; manufacturing process; vector

The purpose of this project is to develop manufacturing capacity at FNLCR to support the multi-center clinical trial GD2-CAR PERSIST or other similar trial for pediatric solid tumors through CITN. The objectives include: (i) tech transfer of existing Prodigy-based manufacturing process, (ii) process development, (iii) assay development, (iv) process qualification, (v) CMC preparation, and (vi) clinical production. Other vector designs may be considered should a change of construct be necessary and resources allow.

该项目的目的是开发FNLCR的生产能力，以支持多中心临床试验GD 2-CAR PERSIST或通过CITN进行的儿科实体瘤的其他类似试验。 这些目标包括：（i）现有基于Prodigy的生产工艺的技术转让，（ii）工艺开发，（iii）测定开发，（iv）工艺鉴定，（v）CMC制备，以及（vi）临床生产。 如果有必要改变构建体并且资源允许，则可以考虑其他载体设计。