Leeds Teaching Hospitals NHS Trust has marked an important milestone in the development of a potential new treatment for people living with difficult-to-treat autoimmune diseases, after the first patient was treated in the CHILL Phase 1/2 clinical study.
The multi-national study, delivered in Leeds by the National Institute for Health and Care Research (NIHR) Clinical Research Facility: Leeds, is evaluating QEL-005, an investigational CD19 B-cell activated engineered regulatory T cell therapy developed by Quell Therapeutics for people with difficult-to-treat rheumatoid arthritis and systemic sclerosis.
Almost half a million people in the UK have rheumatoid arthritis, and an estimated 19,000 have systemic sclerosis and this study is exploring a potential new one-time treatment for these conditions. It involves a new type of ‘cell therapy’ that uses a patient’s own immune cells – called T-regulatory cells or Treg cells – which are collected from the blood, engineered and enhanced in the lab, and then returned to the patient. Regulatory T cells (Tregs) are specialized immune cells that keep the immune system in balance, calming excessive responses and helping prevent tissue damage.
The first participant in the CHILL study received treatment at Leeds Teaching Hospitals, making the Trust the first site worldwide to treat a patient in the trial. Two further patients have since been treated at Oxford University Hospitals NHS Foundation Trust, completing the study’s first dose cohort. Quell Therapeutics has now announced that the study has progressed to its second planned dose cohort following a positive safety review.
The CHILL study is recruiting participants across seven sites in the UK and a further four sites in Germany and Spain. Led in Leeds by Principal Investigator, Professor Francesco Del Galdo and delivered by NIHR Clinical Research Facility: Leeds in close collaboration with clinicians in haematology, including Dr Jonny Carmichael, and rheumatology experts, the trial brings together a multidisciplinary team of research and clinical experts from across the Trust and draws of the expertise and research infrastructure of the NIHR Biomedical Research Centre: Leeds, which supports pioneering research into connective tissue disease 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.”
Dr Jonny Carmichael, consultant haematology at Leeds Teaching Hospitals NHS Trust commented: “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.”
The trial is part of Leeds Teaching Hospitals’ growing portfolio of advanced therapy clinical research and reflects the Trust’s commitment to bringing innovative treatments to patients through research.
If successful, QEL-005 could offer a new transformational treatment approach for people living with complex autoimmune diseases where existing therapies have not provided sufficient benefit. Initial clinical data from the study is expected in 2027.
The CHILL study is delivered by NIHR Clinical Research Facility: Leeds at its state-of the-art clinical research facility at St James University Hospital.
For more detail about the rapid set up of the trial, please visit the Advanced Therapies Treatment Centre website.
For more information about the QUELL study, please visit https://www.chillstudy.life/