RecruitingPhase 1NCT06220201

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).

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Enrollment

120 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Myasthenia Gravis Multiple Sclerosis

Summary

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing CC-97540, an experimental drug, in people with multiple sclerosis (MS) that has continued to worsen despite treatment, or with myasthenia gravis (a muscle-weakening autoimmune disease) that has not responded to standard therapies. The drug is being studied in three separate groups: relapsing MS, progressive MS, and refractory myasthenia gravis. **You may be eligible if...** - You have relapsing MS (Cohort 1): your disability level is moderate (EDSS 3.0–5.5), and your disease has worsened in the past year despite at least 6 months on a high-efficacy MS treatment - You have progressive MS (Cohort 2): you have primary progressive or inactive secondary progressive MS that is treatment-resistant (EDSS 3.0–6.0) - You have myasthenia gravis (Cohort 3): your disease is confirmed by autoantibodies (AChR or MuSK), moderate to severe in classification, and has failed at least 2 immunosuppressant treatments **You may NOT be eligible if...** - You cannot complete the required physical tests (hand and walking tests within time limits) - You have other nerve or muscle disorders that could confuse the study results - You have had a recent MS relapse treated with steroids within 30 days of enrollment - You have more than 20 active brain lesions on MRI at screening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCC-97540

Specified dose on specified days

DRUGFludarabine

Specified dose on specified days

DRUGCyclophosphamide

Specified dose on specified days

Locations(35)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California, Irvine

Irvine, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Yale-New Haven Hospital

New Haven, Connecticut, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Local Institution - 0039

New Orleans, Louisiana, United States

Local Institution - 0005

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Neurological Institute of New York

New York, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Mellen Center

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Swedish Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Antwerp University Hospital

Edegem, Antwerpen, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Hopital Claude Huriez - CHU de Lille

Lille, Nord, France

Pitie Salpetriere University Hospital

Paris, Ville de Paris, France

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Local Institution - 0033

Düsseldorf, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Klinikum der Universität München Großhadern

München, Germany

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0016

Barcelona, Barcelona [Barcelona], Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Manchester Royal Infirmary

Manchester, Lancashire, United Kingdom

University College London Hospital

London, London, City of, United Kingdom

Salford Royal Hospital

Salford, Manchester, United Kingdom

Barts Health NHS Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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