First UK MS patient treated in Phase I CAR-T therapy trial
A CAR T-cell therapy approved for acute lymphoblastic leukemia has now entered a Phase I trial to investigate its potential to slow or halt the progression of multiple sclerosis (MS).
In early October 2025, a clinical research team at University College London Hospitals (UCLH; London, UK) administered the CAR-T therapy Obecabtagene Autoleucel, also known as obe-cel, to a 37-year-old woman with MS. This marks the first instance of CAR T-cell therapy being used to treat MS in the UK as part of a Phase I clinical trial.
Commercially referred to as AUTO1, obe-cel is a B-lymphocyte antigen CD19 CAR T-cell immunotherapy that has previously been studied for its effectiveness in treating blood cancers. This second-generation CAR-T therapy has received approval from the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency for the treatment of acute lymphoblastic leukemia. However, its application in autoimmune diseases, including lupus and MS, remains experimental. Now, Autolus Therapeutics (London, UK), a spinout company from University College London, is conducting the AUTO1-MS1 trial to evaluate the potential of AUTO1 in treating MS, focusing on safety, tolerability and efficacy of AUTO1 in patients with refractory progressive forms of MS.
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MS is a chronic, progressive condition that affects the central nervous system, leading to damage of the protective myelin sheath surrounding nerve fibers. This damage disrupts communication between the brain and the rest of the body, resulting in a range of symptoms that can vary in severity. In the UK, more than 150,000 people are living with MS, and approximately 7,100 new cases are diagnosed each year. “Although treatments for MS have dramatically improved in recent years, none of the available medication fully stops relapses or progression of the illness,” highlighted Wallace Brownlee, the principal investigator of the trial.
The trial aims to evaluate whether AUTO1 can slow MS progression by targeting harmful B cells that attack healthy tissue, including the myelin sheath, a key factor in the disease’s development. AUTO1 CAR-T therapy uses the patient’s own T cells, which are genetically modified to produce chimeric antigen receptors (CARs). These receptors enable the T cells to target and eliminate autoantibody-producing B cells, potentially slowing MS progression. The modified T cells are then infused back into the patient intravenously, potentially leading to long-term remission.
“CAR T-cell therapy is an exciting new frontier in the treatment of autoimmune conditions, and this trial will be essential to understanding the feasibility and safety of CAR-T in people with MS,” expressed Brownlee.
Participants in the trial will be monitored for 24 months following the infusion to assess the safety and effectiveness of AUTO1. After completing the study, participants will be invited to provide consent for a separate long-term safety follow-up study, which will monitor their health for up to 15 years post-infusion.
“Our ultimate goal is to achieve long periods of disease remission with a single, one-time CAR T treatment,” said Claire Roddie, a UCLH consultant hematologist.
The AUTO1-MS1 trial is currently open to UK patients diagnosed with relapsing or progressive forms of MS and are unresponsive to conventional medications.
“We encourage patients aged between 18 and 60 years to speak to their neurologist and explore whether they might be eligible for a referral to this trial,” outlined Frederick Vonberg, a UCL and UCLH neurology research fellow. “The trial aims to recruit up to 18 patients globally by early 2027.”
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