Tuesday 4 August 2026
The National Institute for Health and Care Research (NIHR) Clinical Research Facility (CRF): Manchester successfully set up and recruited the first European patient to a clinical study of a potentially breakthrough treatment called FT819 for a long-term condition called lupus within 124 days – well within the government’s 150 day turnaround target.
This global study is sponsored by Fate Therapeutics, Inc. and is investigating the safety and effectiveness of a promising new approach using a one-time infusion of FT819 – a CAR-T cell therapy – as an investigational treatment to improve the quality of life for people living with lupus and 3 other autoimmune diseases.
NIHR CRF: Manchester – the largest and most comprehensive NIHR CRF – achieved the milestone on a phase 1 study, which opened just 79 days after regulatory approval to begin the study.
Accelerating study set-up times to under 150 days shows the UK can support rapid set-up and recruitment and highlights the specialist experience and expertise of the NIHR’s CRFs, dedicated to delivering commercial and non-commercial, early translational and experimental medicine clinical trials.
Accelerated access to research
Chief Investigator of the study and Director of the NIHR CRF: Manchester, Professor Ben Parker, said;
“We were able to achieve this rapid set-up and European first because of the expertise and experience our CRF teams have in setting up complex early phase cell therapy studies.
“Having undertaken these types of clinical trials previously on the CRF, we were able to move quickly to set up, open and recruit to this study, giving patients speedier access to innovative therapies, through fast and efficient research.”
The 150-day ambition is an early indicator of a broader shift in how the research system operates, moving toward clearer national pathways, stronger coordination and shared accountability across delivery partners.
Succeeding in recruiting the first European patient to this study also demonstrates the incredible impact of NIHR CRFs which work in partnership with commercial sponsors, the life sciences industry and health and care organisations, to accelerate research and give patients faster access to cutting-edge therapies.
Being the first European country to recruit a patient into a global trial is a key indicator for international commercial sponsors when evaluating where to place their studies. It shows that the UK can quickly set up studies and recruit participants.
About the study
In the most serious cases, lupus causes inflammation leading to severe damage to the heart, lungs, brain or kidneys. If proved to be successful, the one-off CAR-T cell therapy could replace regular treatments for patients.
Strong proactive teamwork and agility were key to this recruitment success, with CRF colleagues skilled in the set up and delivery of complex early phase studies, working collaboratively across different hospital and established research departments at the NIHR CRF: Manchester at Manchester Royal Infirmary (MRI).
Prof Parker, who is also a Consultant Rheumatologist at the MRI, added;
“As this study is looking at 4 different conditions, including lupus, it allows more patients to take part, wider access to research and the study set-up processes are more efficient.
“Thank you to all our teams who worked collaboratively to prioritise this and learnings from the rapid setup are being shared as best practice to other participating sites.”
NIHR CRF: Manchester was also the first site globally to recruit a patient with myositis to the study, a condition that causes weak muscles, which slowly gets worse over time. It is now setting up the study for children aged over 12 at Royal Manchester Children’s Hospital.
Spanning 28 purpose-built facilities in NHS hospitals across England, NIHR-funded CRFs encompass world-leading expertise in specific therapeutic areas, highly specialised equipment and access to patient populations.
NIHR CRF: Manchester operates across 6 facilities based at NHS hospitals across Greater Manchester, providing opportunities for people of all ages and backgrounds to take part in innovative and life-changing research. It is hosted by Manchester University NHS Foundation Trust in partnership with The Christie NHS Foundation Trust and Northern Care Alliance NHS Foundation Trust.