Clinical effectiveness of CAR T-cell therapy in MS: ongoing research questions around miv-cel
Jeffrey Dunn, MD, Stanford University School of Medicine, Palo Alto, CA, discusses the key unanswered research questions surrounding the clinical effectiveness of CAR T-cell therapy in multiple sclerosis (MS). Referring to the ongoing trial (NCT06138132) investigating mivocabtagene autoleucel (miv-cel), Prof. Dunn highlights the need for further studies to better understand the therapy’s long-term impact on patient outcomes. This interview took place at the 8th International Workshop on CAR-T and Bispecifics 2026, in Tampa, FL.
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Transcript
We need to be able to see if this medication and this form of treatment is effective on a clinical basis. Even if we could show great results in blood work, that’s meaningful. But at the end of the day, where the rubber meets the road, proverbially speaking, is how patients function on a daily basis. And so in the MS world, we assess patients by what’s called an EDSS, an Expanded Disability Status Scale score, which is imperfect, but it gets at their neurologic functions in multiple domains, including sensation, balance, fatigue, their ability to walk, bowel and bladder function, et cetera, the things that healthy people can take for granted...
We need to be able to see if this medication and this form of treatment is effective on a clinical basis. Even if we could show great results in blood work, that’s meaningful. But at the end of the day, where the rubber meets the road, proverbially speaking, is how patients function on a daily basis. And so in the MS world, we assess patients by what’s called an EDSS, an Expanded Disability Status Scale score, which is imperfect, but it gets at their neurologic functions in multiple domains, including sensation, balance, fatigue, their ability to walk, bowel and bladder function, et cetera, the things that healthy people can take for granted. Assessing those measures, how well the patient is living a normal daily life, how present they are for their family, how well they’re doing at work, are they able to pursue their dreams, are they living like they’ve always wanted to, do they have richness in their lives? Those are critical questions. We need to see if this therapy in the end can achieve those milestones for patients. Can we help stabilize them? Can we help improve their function? That’s a difficult thing to do because the disability evolution in MS can be slow. It can sometimes historically take two, even three years to show a differential between treatment and placebo. Fortunately so far, but in limited numbers, we’re seeing evidence of improvement in disability scale scores in all subjects that we’ve treated so far, even over a six-month time frame, which is very promising. But I underscore these are in limited numbers, and we can’t make a conclusion about efficacy until we have broader numbers and other centers also confirm the results that we’re seeing. With science, as you know, you want to be able to challenge any claim. So I can tell you, I think we’ve seen really promising results, but it’s important too that others see the same things. Working at different centers in different venues, that’s when observations start to become facts.
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