Revolutionizing CAR T-Cell Therapy: A Breakthrough in Patient Care

In a groundbreaking development, medical researchers are aiming to transform the landscape of CAR T-cell therapy, bringing hope to patients around the world and potentially revolutionizing treatment for various diseases. The primary objective is to reduce reliance on third-party industry manufacturing by moving CAR T-cell manufacturing to academic and soon to community oncology centers worldwide, by using mobile clean rooms, and dramatically increasing the number of locations where CAR T-cells can be produced.

One key challenge in the current process involves the transportation of cryopreserved cells, necessitating a constant supply of liquid nitrogen. This limitation may soon become a thing of the past as researchers explore ways to eliminate the need for transportation and thus the need for freezing.

Researchers are focusing on disease indications, especially those related to rare diseases, acknowledging the clinical demand, albeit small, for effective treatments in this area. The introduction of Point of Care (POC) CAR T-cell manufacturing holds the promise of addressing these challenges and bringing this innovative therapy to more patients.

At the forefront of this advancement is the introduction of LV20.19 - bispecific CAR T-cells, specifically designed for use at the Medical College of Wisconsin (MCW) center. Utilizing the Prodigy CliniMACS Manufacturing system at academic centers, the entire process takes just 8 days, and cells can be infused on the same day they are harvested from the CAR T-cell process, eliminating the need for freezing.

Promising results from a Phase 1 clinical trial indicate comparable safety and efficacy with the added potential for enhanced efficacy when using CAR T-cells that have never been frozen. 

Notably, the introduction of POC manufacturing has the added benefit of reducing the costs associated with CAR T-cell therapy. Over the past five years, this innovative approach has already been successfully administered to 10-20 patients per year since 2018, with plans to expand to other medical centers in the near future.

Medical centers in Spain are actively exploring POC CAR T-cell manufacturing, conducting trials to compare its efficacy and safety against the traditional decentralized industry-created CAR T-cell manufacturing process, which involves freezing the cells.

The non-profit organization Caring Costs is taking a bold step by developing mobile clean rooms, building these units to be turn-key and using the same dimensions as a shipping container. These clean rooms can enable POC manufacturing at regional hospitals and for entire regions. The potential global impact is significant, as these mobile clean rooms can be shipped anywhere in the world.

Currently, two companies, CliniMACS Prodigy and Cocoon, have pioneered POC systems for manufacturing CAR T-cells. Europe is leading the charge in POC manufacturing, offering a glimpse into the future where cryopreservation may become obsolete, potentially leading to even more potent CAR T-cells and expanding access to this transformative therapy on a global scale.

Picture of CliniMACS Prodigy at Tandem 2024 exhibit hall