Quell Therapeutics and The Newcastle upon Tyne Hospitals NHS Foundation Trust, an ATTC network site, worked in collaboration with the NIHR Industry Hub, which provides a national single point of contact to support sponsor-site collaboration. Together, they enabled delivery of a first of its kind CAR-Treg study in the UK through early and continuous sponsor engagement, the site-level Operational Group for Advanced Therapies, NIHR Clinical Research Facility infrastructure and delivery team, and parallel review processes. This enabled faster delivery of Quell Therapeutics’ Phase 1/2 trial, CHILL, involving a CD19 CAR-Treg cell therapy for difficult-to-treat rheumatoid arthritis and systemic sclerosis.

Advanced therapy trials are highly complex and often face extended, unpredictable timelines. Through a coordinated approach involving haematology and apheresis teams, the NIHR Clinical Research Facility delivery team, the Operational Group for Advanced Therapies, and Quell Therapeutics, with support from the NIHR Industry Hub as a single point of contact for sponsor-site collaboration and faster costings, key operational barriers were addressed early.

The study achieved a total start up metric of 113 days, aligning with the UK Government’s policy ambition to reduce trial set up timelines to less than 150 days.

This approach directly supports national priorities outlined in policy reviews to enhance clinical trial delivery and strengthen the UK’s global competitiveness. By demonstrating a scalable, collaborative model, the ATTC network and NIHR are helping to enable faster, more predictable trial activation and earlier patient access to innovative therapies.

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