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NCT06220201Active, not recruitingPhase 1

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)

A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
120 (estimated)
First submitted
4 Jan 2024
Start date
28 Mar 2024
Primary completion date
15 Jul 2027
Lead sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
NCT number
NCT06220201
EudraCT number
2023-507820-22

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 120
  • From 28 Mar 2024 to the primary completion date, 15 Jul 2027
  • 34 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • 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

  • Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \< 150 seconds.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • \- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1.
  • Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.
  • 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.
  • Participants must have an EDSS ≥ 3.0 and ≤ 6.0.
  • 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
  • Documentation of autoantibodies against AChR or MuSK (historical or at Screening)
  • Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.
  • Has had thymectomy, only if indicated according to current guidelines.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Antwerp University Hospital
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EdegemBelgiumUnknown status
UZ Gent
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GhentBelgiumUnknown status
Local Institution - 0033
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DüsseldorfGermanyUnknown status
Universitaetsklinikum Erlangen
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ErlangenGermanyUnknown status
Universitaetsklinikum - Essen
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EssenGermanyUnknown status
Universitaetsklinikum Magdeburg
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MagdeburgGermanyUnknown status
Klinikum der Universität München-Großhadern
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MünchenGermanyUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Local Institution - 0016
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BarcelonaSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Hopital Claude Huriez - CHU de Lille
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LilleFranceUnknown status
Pitié-Salpêtrière University Hospital
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ParisFranceUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
Manchester Royal Infirmary
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ManchesterUnited KingdomUnknown status
Salford Royal Hospital
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SalfordUnited KingdomUnknown status
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesUnknown status
Local Institution - 0011
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BirminghamUnited StatesUnknown status
Local Institution - 0005
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BostonUnited StatesUnknown status
University of Cincinnati Medical Center
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CincinnatiUnited StatesUnknown status
Cleveland Clinic Mellen Center
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ClevelandUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
University of California, Irvine
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IrvineUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Neurological Institute of New York
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Yale-New Haven Hospital
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North HavenUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Swedish Medical Center
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SeattleUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.