The Newcastle upon Tyne Hospitals NHS Foundation Trust successfully became the first site to activate a clinical trial for autoimmune disease through a governance-led, multidisciplinary approach to advanced therapy trial readiness and study set-up.  

The CHILL Phase 1/2 study, sponsored by Quell Therapeutics, is investigating a cutting-edge chimeric antigen receptor (CAR) regulatory T-cell (Treg)  cell therapy for people living with difficult-to-treat rheumatoid arthritis and systemic sclerosis. Regulatory T cells (Tregs) alter the immune system to help control inflammation, seen in conditions like rheumatoid arthritis. 

The study was delivered within a governance-led operational framework developed at Newcastle Hospitals to strengthen advanced therapy trial readiness, sponsor engagement, multidisciplinary coordination and study set-up. The work involved collaboration across Newcastle Hospitals and partner organisations, including the NIHR Industry Hub and the Northern Alliance Advanced Therapies Treatment Centre (NA-ATTC). The NA-ATTC also supported advanced therapy research capability at Newcastle Hospitals through investment in an ATIMP trials manager. 

Although Newcastle Hospitals has an established history of delivering advanced therapy studies, operational review highlighted recurring challenges affecting readiness and study setup. These included fragmented communication between stakeholders, duplication of effort, delayed identification of operational risks, inconsistent recognition and classification of ATIMP studies, workforce capability gaps, sponsor-related challenges and uncertainty regarding approval pathways.   

To address these challenges, Newcastle Hospitals brought together expertise from Newcastle Advanced Therapies, NIHR Clinical Research Facility (CRF): Newcastle, Pharmacy Clinical Trials, Newcastle Joint Research Office (NJRO), Freeman Hospital and representatives from the Northern Alliance ATTC. These members worked together through the governance-led operational framework to improve study activation, strengthen operational readiness and develop sustainable organisational capability for advanced therapy clinical trials. 

The CHILL study also demonstrated the value of early sponsor partnership and cross-site collaboration. Newcastle worked closely with the NCVR lead site and contributed to the development of ATIMP costing approaches, supporting a coordinated approach to complex advanced therapy study delivery.   

Operational approach to accelerated study start-up.

Newcastle Hospitals implemented a streamlined ATIMP set up model with three core components: 

• Early and continuous sponsor engagement and readiness assessment 

• A dedicated Operational Group for Advanced Therapies 

• Parallel and coordinated governance and operational review  

Why CHILL succeeded: 

• Early sponsor partnership from study design through activation 

• A single coordinated ATIMP operational leadership model 

• Parallel rather than sequential governance and approval processes 

• Cross-specialty expertise and multidisciplinary collaboration within the site 

• Cross-site collaboration with the NCVR lead site 

• A sponsor-focused delivery model designed to reduce uncertainty and support timely decision-making 

The study was opened in just 113 days, well within the UK’s 150-day national target, demonstrating an efficient and coordinated approach to complex ATIMP study set-up. This success demonstrates how a governance-led operational approach combining early sponsor engagement, coordinated operational leadership, multidisciplinary collaboration and parallel review processes can support efficient advanced therapy trial delivery. 

The approach may provide a useful and adaptable model for other NHS organisations seeking to strengthen readiness for advanced therapy clinical trials.