GD2 CAR T MANUFACTURING

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

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.