First patient dosed in world-first study exploring potential one-time treatment for rheumatoid arthritis and systemic sclerosis
Leeds Teaching Hospitals NHS Trust has reached a significant milestone in the development of a potential new treatment for people living with severe autoimmune diseases, becoming the first site globally to treat a patient in the pioneering CHILL Phase 1/2 clinical trial.
The international study is assessing QEL-005, an investigational engineered regulatory T-cell (Treg) therapy developed by Quell Therapeutics for patients with difficult-to-treat rheumatoid arthritis and systemic sclerosis. Delivered in Leeds through the NIHR Clinical Research Facility: Leeds, the trial represents a major step forward in the application of advanced cell therapies for autoimmune conditions.
Rheumatoid arthritis affects almost 500,000 people across the UK, while systemic sclerosis impacts an estimated 19,000 individuals. Despite existing treatments, many patients continue to experience debilitating symptoms and disease progression, driving the need for innovative therapeutic approaches.
The CHILL study is investigating a novel form of cell therapy that uses a patient's own immune cells. Regulatory T cells are collected from the bloodstream, engineered and enhanced in specialist laboratories, and then reintroduced into the patient. These cells play a vital role in maintaining immune system balance by suppressing excessive immune responses and helping to prevent tissue damage.
The first participant in the trial received treatment at Leeds Teaching Hospitals NHS Trust, establishing the organisation as the first site worldwide to administer the therapy. Since then, two additional patients have been treated at Oxford University Hospitals NHS Foundation Trust, completing the study's first dose cohort.
Following a positive safety review, Quell Therapeutics has confirmed the study has now advanced into its second planned dose cohort.
The CHILL trial is recruiting participants across 11 centres, including seven sites in the UK and four across Germany and Spain. In Leeds, the study is led by Professor Francesco Del Galdo and delivered through the NIHR Clinical Research Facility: Leeds, working closely with haematology and rheumatology specialists from across the Trust.
The research also draws on the expertise and infrastructure of the NIHR Biomedical Research Centre: Leeds, which supports leading research into connective tissue and autoinflammatory diseases.
Prof Francesco Del Galdo, Principal Investigator at Leeds Teaching Hospitals NHS Trust, said:
“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.”
Professor Chris Twelves, Director of the NIHR Clinical Research Facility: Leeds, said:
“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.”
The study forms part of Leeds Teaching Hospitals’ expanding advanced therapy research programme, underlining the Trust’s commitment to providing patients with access to cutting-edge treatments through clinical research.
If successful, QEL-005 could offer a transformative, one-time treatment option for patients whose autoimmune diseases have not responded adequately to existing therapies. Initial clinical data from the study is expected in 2027.
The trial is being conducted at the state-of-the-art NIHR Clinical Research Facility at St James’s University Hospital in Leeds.
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