Could CAR t cells tame autoimmune brain diseases?
NCT ID NCT06220201
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 6 times
Summary
This early-stage trial tests a new treatment called CC-97540, which uses a patient's own immune cells engineered to target and destroy harmful immune cells. The study includes 120 people with relapsing or progressive multiple sclerosis or refractory myasthenia gravis. The main goal is to check safety and find the right dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CC-97540 (CAR T cells targeting CD19)
- What this could lead to
- If successful, this could lead to a new treatment option that controls autoimmune neurological diseases like MS and myasthenia gravis by targeting faulty immune cells.
- What could go wrong
- This is an early Phase 1 trial focused on safety, so it is too soon to know if it works. CAR T cell therapy can cause serious side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria \- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1. i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5. ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months. \- Progressive forms of MS - Cohort 2. i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0. ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS). \- Myasthenia Gravis - Cohort 3 i)MGFA classification of II-IV at screening ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening) iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics. iv) Has had thymectomy, only if indicated according to current guidelines. Exclusion Criteria * Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in \<240 seconds unless extenuating medical conditions unrelated to MS prohibit this. * Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \< 150 seconds. * Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome. * Other protocol-defined Inclusion/Exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Antwerp University Hospital
Edegem, Antwerpen, 2650, Belgium
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Barts Health NHS Trust
London, E1 1RD, United Kingdom
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Cleveland Clinic Mellen Center
Cleveland, Ohio, 44195, United States
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59000, France
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Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
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Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
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Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034, Spain
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Klinikum der Universität München Großhadern
München, 81337, Germany
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Local Institution - 0005
Boston, Massachusetts, 02114, United States
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Local Institution - 0011
Birmingham, Alabama, 35294, United States
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Local Institution - 0016
Barcelona, Barcelona [Barcelona], 08035, Spain
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Local Institution - 0033
Düsseldorf, 40225, Germany
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Manchester Royal Infirmary
Manchester, Lancashire, M20 2RZ, United Kingdom
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Neurological Institute of New York
New York, New York, 10032, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Pitie Salpetriere University Hospital
Paris, Ville de Paris, 75013, France
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Salford Royal Hospital
Salford, Manchester, M6 8HD, United Kingdom
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Swedish Medical Center
Seattle, Washington, 98122, United States
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UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
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Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
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Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
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Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
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University College London Hospital
London, London, City of, NW1 2PG, United Kingdom
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University of California, Irvine
Irvine, California, 92697, United States
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Yale-New Haven Hospital
North Haven, Connecticut, 06473, United States
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Other studies related to the condition(s) this trial covers.
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