Three patients in the UK have received an innovative CAR T-cell therapy as part of the CARLYSE Phase 1 clinical trial, offering new hope for individuals with severe lupus. The trial, led by University College London Hospitals (UCLH) and UCL, and sponsored by Autolus, aims to evaluate the potential of CAR T-cell therapy to reduce or eliminate the need for lifelong medication in severe lupus cases.
Groundbreaking Trial for Lupus Treatment
The CARLYSE trial marks the first instance in the UK of CAR T-cell therapy being tested for a non-cancer autoimmune disease. Lupus, or systemic lupus erythematosus (SLE), is a chronic condition where the body's immune system attacks healthy tissues and organs. Affecting approximately 69,000 people in the UK, lupus can lead to life-threatening complications, with current treatments focusing on symptom management and reducing organ damage, often with significant side effects.
Professor Ben Parker, Consultant Rheumatologist at the Kellgren Centre for Rheumatology and study lead at the Manchester Royal Infirmary (MRI), emphasized the potential of this research to revolutionize lupus treatment. "We are delighted to be the first to deliver this fantastic research in the UK, which we hope will revolutionise treatment for patients with high-risk lupus, that could potentially lead to a cure for the disease," he stated.
CAR T-Cell Therapy: A New Approach
CAR T-cell therapy involves modifying a patient's own T cells to express a chimeric antigen receptor (CAR) that specifically targets and destroys B cells, which are implicated in the autoimmune response in lupus. This approach builds on research conducted over the past 25 years at UCL and UCLH, which has demonstrated the benefits of B cell depletion in certain autoimmune diseases.
Dr. Maria Leandro, UCLH Consultant Rheumatologist and Honorary Associate Professor at the UCL Division of Medicine, highlighted the potential of CAR T-cell therapy in autoimmune diseases, drawing parallels with its success in treating blood cancers. "We have seen the effectiveness of CAR-T in cancer, particularly blood cancers, and hope we can replicate this in autoimmune diseases, starting with lupus," she said.
The trial seeks to recruit 12 participants worldwide and aims to replicate the positive outcomes observed in a small German trial, which showed improvements in lupus patients treated with CAR T-cell therapy.
Patient Perspective
Katie Tinkler, a 50-year-old former fitness instructor with severe lupus, is among the first participants in the trial. Diagnosed with lupus at age 20, Tinkler has experienced debilitating pain, fatigue, and other complications, including antiphospholipid syndrome and kidney disease. She expressed her excitement about the potential of CAR T-cell therapy to offer a possible cure for lupus, stating, "Up until now, there’s never been anything for lupus that is a possible cure."
Collaborative Effort
The CARLYSE trial is a collaborative effort involving rheumatology, haematology, and cancer services at multiple institutions. Dr. Eleni Tholouli, Consultant Haematologist and Director of the Adult Stem Cell Transplant and CAR-T Unit at MRI, noted the significance of this collaboration, stating, "For us at MFT, this is the first trial to be co-delivered by rheumatology and haemato-oncology teams and marks a real step forward in how we are utilising our expertise at MFT to deliver ground-breaking research for the benefit of our patients."
UCLH Consultant Haematologist and UCL Cancer Institute researcher Claire Roddie added, "It is fantastic to be involved in the wider development of the UCL-innovated, ‘low toxicity’ CAR-T therapeutic AUTO1/obe-cel for patients with refractory lupus."
