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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)
NCT06220201 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
In plain English
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Official title
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).
About this study
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).
Eligibility criteria
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.
Study design
Enrollment target: 120 participants
Allocation: non_randomized
Masking: none
Age groups: adult
Timeline
Starts: 2024-03-28
Estimated completion: 2027-07-15
Last updated: 2026-02-10
Interventions
Drug: CC-97540Drug: FludarabineDrug: Cyclophosphamide
Primary outcomes
- • Number of participants with adverse events (AEs) (Up to week 104)
- • Number of participants with serious adverse events (SAEs) (Up to week 104)
- • Number of participants with adverse events of special interest (AESIs) (Up to week 104)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · industry
With: Celgene Corporation
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (35)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of California, IrvineRecruiting
Irvine, California, United States
University of Colorado Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
Yale-New Haven HospitalRecruiting
New Haven, Connecticut, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Local Institution - 0039Withdrawn
New Orleans, Louisiana, United States
Local Institution - 0005Completed
Boston, Massachusetts, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Neurological Institute of New YorkRecruiting
New York, New York, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Cleveland Clinic Mellen CenterRecruiting
Cleveland, Ohio, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Antwerp University HospitalRecruiting
Edegem, Antwerpen, Belgium
UZ GentRecruiting
Ghent, Oost-Vlaanderen, Belgium
Hopital Claude Huriez - CHU de LilleRecruiting
Lille, Nord, France
Pitie Salpetriere University HospitalRecruiting
Paris, Ville de Paris, France
Universitaetsklinikum EssenRecruiting
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum MagdeburgRecruiting
Magdeburg, Saxony-Anhalt, Germany
Local Institution - 0033Completed
Düsseldorf, Germany
Universitaetsklinikum ErlangenRecruiting
Erlangen, Germany
Klinikum der Universität München GroßhadernRecruiting
München, Germany
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0016Not Yet Recruiting
Barcelona, Barcelona [Barcelona], Spain
Hospital Clínic de BarcelonaRecruiting
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Manchester Royal InfirmaryRecruiting
Manchester, Lancashire, United Kingdom
University College London HospitalRecruiting
London, London, City of, United Kingdom
Salford Royal HospitalRecruiting
Salford, Manchester, United Kingdom
Barts Health NHS TrustRecruiting
London, United Kingdom