Three patients in the UK have received an innovative treatment for the most serious form of lupus – an autoimmune condition which can cause damage to the heart, lungs, joints, brain or kidneys.
Researchers hope that the one-off CAR-T (Chimeric Antigen Receptor T-cell) therapy will reduce, or even remove, the need for life-long medication for patients with severe lupus.
The international Phase 1 study, called CARLYSE, is the first in the UK to assess the potential of CAR-T therapy to treat a disease other than cancer. It is led by UCLH and UCL and sponsored by Autolus.
There are three participating sites, with Manchester recruiting the first patient nationally at the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) at Manchester Royal Infirmary (MRI).
Lupus (systemic lupus erythematosus, or SLE) is a long-term condition which occurs when the body's own immune system attacks healthy parts of the body, which can be life-threatening. Although there are different drugs that can help relieve many of the symptoms from mild to severe, and reduce the chances of organ damage, these drugs can have unwanted side-effects and can even stop working.
Approximately 69,000 people in the UK have lupus. The causes of lupus are not fully understood and there is currently no cure for the condition. Side effects can include joint and muscle pain, skin rashes and extreme tiredness.
Professor Ben Parker, Consultant Rheumatologist at the Kellgren Centre for Rheumatology and study lead at the MRI, part of Manchester University NHS Foundation Trust (MFT) said: “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.
“Lupus is a disease that requires life-long medication, but this therapy has the potential to change that, which is incredibly exciting.”
Lupus is an uncommon condition with around 90 per cent of cases occurring in women. The condition tends to appear between the ages of 15 and 50 and is more common in people with an African, Caribbean, Asian or Chinese background.
UCLH Consultant Rheumatologist and Honorary Associate Professor at the UCL Division of Medicine, Dr Maria Leandro said: “This trial builds on the research UCL and UCLH rheumatologists have been conducting for the past 25 years on the benefits of killing B cells in some autoimmune diseases. 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.
“Our early phase trial aims to recruit 12 people worldwide and we hope to replicate the results of a small German trial which showed an improvement in lupus patients treated with CAR-T cell therapy. This kind of innovative research work only becomes possible with close collaboration from teams in rheumatology, renal medicine and haematology.”
UCLH Consultant Haematologist and UCL Cancer Institute researcher Claire Roddie said it is "hugely exciting to be able to offer this novel treatment to our lupus patients."
Dr Eleni Tholouli, Consultant Haematologist and Director of the Adult Stem Cell Transplant and CAR-T Unit at MRI, and Sub Investigator of the study, said: “We have been delivering cutting-edge CAR-T therapy to cancer patients at MFT since 2018, and we have seen remarkable benefits to patients and results during this time.
“It is an incredibly exciting time to now offer this mode of treatment to lupus patients through this clinical trial, which we hope will provide positive outcomes and revolutionise treatment options for patients with the disease.
“I am incredibly proud to be part of this exciting research journey and it has been a real team effort to deliver this complex investigational therapy. 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.”
Photo credit: Lucy North/PA Media
