MyoCon! September 24–27, 2026.
If you’ve been following developments in myositis research, you’ve probably heard recent news that Novartis and Bristol Myers Squibb (BMS) have paused certain clinical trials of experimental CAR T-cell therapies for autoimmune diseases, including idiopathic inflammatory myopathies (IIM). While headlines about trial pauses can sound concerning, this is how the clinical research process is designed to work.
Novartis announced a temporary pause in its AUTOGRAPH clinical trial program after three participants experienced a rare but serious immune reaction known as immune effector cell-associated hemophagocytic syndrome (IEC-HS). Sadly, the cases of IEC-HS led to fatal complications. The company has halted enrollment and treatment while investigators and regulators carefully review the data.
Bristol Myers Squibb also announced a pause in parts of its autoimmune CAR T-cell program, including Breakfree-1, after observing inflammatory side effects that the company described as transient and reversible. No deaths have been reported in connection with the BMS program.
These pauses give investigators, regulators, and trial sponsors an important opportunity to better understand what occurred, identify any contributing factors, and determine the safest path forward for participants. Patient safety is always the highest priority in clinical research. Institutional Review Boards (IRBs) will be monitoring the outcome of these pauses as they consider the risk/benefit for their patients.
A Pause Is Not the End of the Road
A trial pause does not necessarily mean that the experimental treatment is a failure. Clinical trials include multiple layers of safety monitoring specifically designed to detect unexpected issues. When researchers identify potential concerns or adverse effects, studies may be paused so the information can be thoroughly reviewed. In many cases, trials resume after adjustments are made to monitoring procedures, eligibility criteria, dosing approaches, or other safeguards.
In fact, the willingness of sponsors to pause, investigate, and learn from unexpected events is one of the reasons patients and physicians can have confidence in the clinical trial process.
Cell therapy represents an exciting new direction for the treatment of autoimmune conditions like myositis. Many clinical trial programs for different cell therapies and different autoimmune diseases are underway, and some potentially promising data has been published.
Much is still unknown about these treatments, however, including long-term impact, how long the therapeutic effects may last, and if there are unexpected effects. Those who may consider participating in a cell therapy clinical trial should proceed with a great deal of caution and ask as many questions as necessary to be sure they are comfortable with all the possible downsides of the trial.
An Exciting Time for Myositis Research
We continue to be encouraged by recent news highlighting remarkable momentum in myositis science. The myositis community has recently celebrated important developments from companies including Abcuro, argenx, and Priovant. New therapies are advancing through the clinical development pipeline, and researchers are gaining a deeper understanding of the forms of myositis.
This year’s MyoCon reflects that momentum, featuring three sessions devoted specifically to clinical trials in myositis. Leading global researchers will discuss the current state of myositis studies and what may be on the horizon. In addition, patients who have participated in clinical trials will share their real-world experiences and insights. These conversations are especially valuable as our community works to understand both the promise and the challenges of emerging therapies such as CAR T-cell treatments.
Moving Forward with Hope and Caution
Clinical trials are the bridge between scientific discovery and future treatment options. They require tremendous commitment from the pharmaceutical industry and investigators – and especially from patients who volunteer to participate.
The recent pauses by Novartis and BMS demonstrate that the safeguards built into clinical research are doing exactly what they are intended to do: identifying potential risks, protecting participants, and ensuring that new therapies meet the highest standards of safety and effectiveness before reaching patients.
While questions remain about the future of these specific studies, the broader story remains one of progress and hope. Researchers around the world continue to pursue new and better treatments for myositis, and every lesson learned through clinical research brings us one step closer to that goal.
Learn More
Join us at MyoCon 2026.
Read TMA’s special themed issue of The Outlook focused on Clinical Trials.
Read TMA’s special themed issue of The Outlook focused on Cell Therapy.
