Leeds Teaching Hospitals Treats First Patient in Pioneering Cell Therapy Study
New investigational treatment for difficult-to-treat autoimmune diseases, QEL-005, shows promise in early-stage clinical trial.
By Leah Sutcliffe
••4 min read
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Generic image of a laboratory vial with a blurred background of medical equipment and a Yorkshire landscape.
Leeds Teaching Hospitals NHS Trust has become the first site worldwide to treat a patient in the CHILL Phase 1/2 clinical study, evaluating a potential new cell therapy for difficult-to-treat autoimmune diseases.
The Leeds Teaching Hospitals NHS Trust has reached a significant milestone with the first patient treated in the CHILL Phase 1/2 clinical study, exploring a novel treatment for severe autoimmune conditions. The multi-national study, conducted locally by the NIHR Clinical Research Facility: Leeds, is assessing QEL-005, an engineered T-regulatory cell therapy developed by Quell Therapeutics. This investigational treatment is designed for individuals suffering from challenging forms of rheumatoid arthritis and systemic sclerosis.
Rheumatoid arthritis affects nearly half a million people in the UK, while an estimated 19,000 live with systemic sclerosis. The CHILL study investigates a potential one-time treatment using a patient's own modified immune cells, known as T-regulatory cells (Tregs). These cells are engineered to help rebalance the immune system, mitigating excessive responses and preventing tissue damage.
Following the successful treatment of the first participant at Leeds Teaching Hospitals, the Trust became the trial's inaugural global site. Two additional patients have since been treated at Oxford University Hospitals NHS Foundation Trust, completing the study's initial dose cohort. Based on positive safety reviews, Quell Therapeutics has announced the study's progression to its second planned dose cohort.
The CHILL study is currently recruiting across seven UK sites and four in Germany and Spain. The Leeds-based arm is led by Principal Investigator, Professor Francesco Del Galdo, in close collaboration with experts in haematology, including Dr Jonny Carmichael, and rheumatology. The trial leverages the expertise of the NIHR Biomedical Research Centre: Leeds, which focuses on connective tissue and autoinflammatory diseases.
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"We were thrilled to see the first CHILL patient globally receive this new intervention at Leeds Teaching Hospitals. Patient safety was central to our preparations, with the multidisciplinary team working closely together to support and monitor the patient throughout. The team worked together admirably and it was rewarding to see the patient able to return home the following day after dosing."
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"At Leeds Teaching Hospitals, we have extensive experience delivering early-phase advanced therapy trials safely and effectively, especially for people with blood cancers. The CHILL study is the first time we have brought together specialist teams across the Trust and colleagues at the University of Leeds to deliver this type of advanced therapy for autoimmune disease. We’re delighted to be the first site to safely recruit and commence treatment to the first patient within two weeks of the trial opening. This has been possible thanks to close collaboration and commitment of our specialist clinical and research teams working together. By exploring whether these innovative treatments are safe and effective in conditions that are difficult to treat, we hope to pave the way for new treatments for patients in the future."
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"In advanced therapy such as this, collaboration is essential. By bringing together the rheumatology, haematology and NIHR CRF: Leeds teams from Leeds Teaching Hospitals NHS Trust and the University of Leeds, we brought together the expertise to identify suitable participants, navigate the complexities of trial delivery and deliver high-quality innovative care for our patients, ensuring we deliver research safely and efficiently."
This trial is a key part of Leeds Teaching Hospitals’ expanding portfolio of advanced therapy clinical research, underscoring the Trust's dedication to offering patients innovative treatments through research. If successful, QEL-005 could represent a transformative new treatment option for individuals with complex autoimmune diseases who have not found sufficient benefit from current therapies. Initial clinical data from the study is anticipated in 2027. The CHILL study is being conducted at the NIHR Clinical Research Facility: Leeds, located at St James University Hospital.
