Ultra-fast manufactured CAR-T therapy

Kure. Ai, Inc., Shaker Heights OH

Investigators

Abstract

Novel therapeutic approaches are urgently needed for patients with relapsed/refractory cancers. Chimeric Antigen Receptor (CAR) T cell therapies have exhibited remarkable promise particularly for patients with relapsed/refractory B cell malignancies. Though current CAR-T therapies including FDA approved CD19 CAR-T products demonstrate efficacy in patients, there are still major hurdles including high relapse rates and toxicities. In addition, there are major issues with costs and accessibility of these products worldwide that are largely due to the expensive and complex manufacturing processes. We have developed an ultra-fast (UF) CAR- T manufacturing process that enables the production of CAR-T product in less than one day using a simple and inexpensive workflow. Not only does the workflow improve the manufacturing process, but the product also exhibits high promise to provide a product with significantly improved efficacy and safety as compared to traditionally manufactured CAR-T cells. We developed an initial CAR-T product, UF-Kure19, using this ultra-fast, less than 1 day manufacturing workflow for which we just completed an initial phase 1 clinical trial. This trial involved the treatment of 10 patients with relapsed/refractory non-hodgkin’s lymphoma and led to an extremely promising safety and efficacy profile (80% complete remission rate). Through this grant we aim to further develop this rapid CAR-T product by performing our next phases of clinical development. Our objectives for this study are 1) To validate an automated, closed system process for our manufacturing through a phase1b clinical trial and 2) To extend our safety/efficacy clinical data in a defined subpopulation of patients with aggressive lymphoma that often require rapid treatment delivery. It is hoped that this work will lead to a product for lymphoma patients that demonstrates significantly improved efficacy and safety as compared to the current FDA approved agents.