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Could CAR t cells tame autoimmune brain diseases?

NCT ID NCT06220201

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

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

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

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650, Belgium

  • Barts Health NHS Trust

    London, E1 1RD, United Kingdom

  • Cleveland Clinic Mellen Center

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord, 59000, France

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Klinikum der Universität München Großhadern

    München, 81337, Germany

  • Local Institution - 0005

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0011

    Birmingham, Alabama, 35294, United States

  • Local Institution - 0016

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Local Institution - 0033

    Düsseldorf, 40225, Germany

  • Manchester Royal Infirmary

    Manchester, Lancashire, M20 2RZ, United Kingdom

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Neurological Institute of New York

    New York, New York, 10032, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Pitie Salpetriere University Hospital

    Paris, Ville de Paris, 75013, France

  • Salford Royal Hospital

    Salford, Manchester, M6 8HD, United Kingdom

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitaetsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitaetsklinikum Magdeburg

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • University College London Hospital

    London, London, City of, NW1 2PG, United Kingdom

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale-New Haven Hospital

    North Haven, Connecticut, 06473, United States

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