UK clinical
research update

• World-first lupus trial in the UK delivers life-changing CAR-T therapy
  The UK has become the first country in the world to recruit for investigational lupus CAR-T therapy. This global milestone is a result of a collaboration between Autolus, Cambridge University Hospitals, and the NIHR. The partnership enabled the UK to rapidly activate this complex phase II trial of the investigational treatment to participants faster than sites in the US and Greece. Read the full story.  
• NHS Tayside world first participant
  The University of Dundee and NHS Tayside have recruited the world’s first participant to an international study assessing a new combination treatment for adults with advanced chronic kidney disease (CKD). Sponsored by AstraZeneca, the BalanceD-CKD study will assess whether balcinrenone combined with dapagliflozin reduces renal and cardiovascular risks more effectively than dapagliflozin alone in patients with Stage 3b and 4 CKD.In an exceptional display of operational readiness, the study team at NHS Tayside recruited the first participant on the same day the study opened, becoming the first in Europe and the world to recruit to the study. Read the full story.
• World-First Trial of Fridge-Free Vaccine shows encouraging results
  A UK-led Phase I trial has delivered encouraging results for a world-first fridge-free tetanus-diphtheria vaccine (SPVX02) that remains stable without refrigeration. Delivered through the NIHR Clinical Research Facility and Biomedical Research Centre in Southampton, the study showed that the reformulated vaccine provides protective antibody levels comparable to standard licensed vaccines, while remaining stable at temperatures up to 30°C for at least two years. This achievement demonstrates how cutting-edge UK science is leading the charge in trialling revolutionary healthcare innovations expanding access to life-saving treatments. Read more on the NIHR and HRA’s websites. 

• Peer support helps more GP practices adopt the National Contract Value Review
  While NCVR is mandatory for NHS trusts, joining remains voluntary for primary care. To support uptake, NHS England funded dedicated primary care NCVR champion roles through the NIHR Research Delivery Network (RDN). Over 3 months, the NCVR champions worked directly with GP practices to explain how the process works, answer questions and share practical experience. Read the full story. 
• First European patient recruited to global study within 124 days
  NIHR CRF Manchester successfully set up and recruited the first European patient to a study of a potentially breakthrough treatment for Lupus within 124 days. The global study, sponsored by Fate Therapeutics, Inc. 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 autoimmune diseases. Accelerating study set-up times to under 150 days shows the UK can support rapid set-up and recruitment. Read the full story.
• Serotonin-targeting drug shows promise as potential new treatment for depression
  Researchers from NIHR Biomedical Research Centre (BRC): Oxford Health Depression Therapeutics Theme have published new study findings that could help pave the way for a new generation of treatments for depression. The RESTAND study demonstrated that a novel selective serotonin 4 receptor agonist works differently from standard antidepressants to deliver rapid benefits.
  This early-stage breakthrough highlights the UK’s world-leading experimental medicine capabilities and provides important evidence that could represent a promising new direction for depression treatment. Read the full story.

We’re keen to hear about and share success stories about improvements across the system. Please send yours to: ukcrdprogramme@dhsc.gov.uk.

Read more about how UKCRD efforts are helping to make the UK a world leader in clinical trials on the UKCRD news page.