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CAR-T Cell Product Development Guidance Covers Previous Recipients, ‘Bridging Therapy’

 
• By Sue Sutter

Testing of autologous therapy in clinical trial patients who previously received CAR-T cells requires special consideration in initial material testing and study design, US FDA says in a draft guidance that also addresses potential need for bridging therapy in the event of a manufacturing delay or failure.

Bridge
Sponsors may need to consider 'bridging therapy' in their CAR-T study protocols. • Source: Alamy

A new US Food and Drug Administration guidance addresses unique challenges in chimeric antigen receptor T-cell product development, including when clinical trial subjects previously have received CAR-T cells and when “bridging therapy” may be needed in the event of a manufacturing delay or failure.

The draft guidance discusses clinical considerations for early-phase development specific to CAR-T products for cancer patients, with particular attention to the appropriate study population and treatment plan aspects

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