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 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: CA061-10062023-507820-22U1111-1296-8579
• Study Type: interventional
• Target: 120
• Locations: 6 countries
• Sites: 35

Brief 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).

Conditions

Multiple Sclerosis; Myasthenia Gravis

Keywords

CC-97540; CAR T; CART; NEX T; NEXT; BMS-986353; RMS; PMS; Multiple sclerosis; RRMS; aSPMS; PPMS; iSPMS; MG; gMG; refractory myasthenia gravis; general myasthenia gravis; CD19

Outcome Measures

Primary Outcomes (7)

• 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

• Number of participants with laboratory test result abnormalities

  Up to week 104

• Number of participants with imaging abnormalities

  For Cohorts 1 and 2

  Up to week 104

• Number of participants with dose-limiting toxicities (DLTs)

  Up to week 104

• Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period

  Up to week 104

Secondary Outcomes (12)

• Number of participants meeting no evidence of disease activity (NEDA) criteria

  Up to week 104

• Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)

  Up to week 12

• Annualized relapse rate

  Up to week 104

• Change from baseline in magnetic resonance imaging (MRI) metrics

  Up to week 104

• Number of participants with disability improvement confirmed per EDSS

  Up to week 12

Study Arms (3)

Administration of CC-97540 (RMS arm)

EXPERIMENTAL

Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide

Administration of CC-97540 (PMS arm)

EXPERIMENTAL

Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide

Administration of CC-97540 (MG arm)

EXPERIMENTAL

Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

CC-97540 DRUG

Specified dose on specified days

Also known as: BMS-986353

Administration of CC-97540 (MG arm); Administration of CC-97540 (PMS arm); Administration of CC-97540 (RMS arm)

Cyclophosphamide DRUG

Specified dose on specified days

Administration of CC-97540 (MG arm); Administration of CC-97540 (PMS arm); Administration of CC-97540 (RMS arm)

Fludarabine DRUG

Specified dose on specified days

Administration of CC-97540 (MG arm); Administration of CC-97540 (PMS arm); Administration of CC-97540 (RMS arm)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene Corporation: collaborator
• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (35)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Local Institution - 0039

New Orleans, Louisiana, 70121, United States

WITHDRAWN

Local Institution - 0005

Boston, Massachusetts, 02114, United States

COMPLETED

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Neurological Institute of New York

New York, New York, 10032, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic Mellen Center

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Hopital Claude Huriez - CHU de Lille

Lille, Nord, 59000, France

RECRUITING

Pitie Salpetriere University Hospital

Paris, Ville de Paris, 75013, France

RECRUITING

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Universitaetsklinikum Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Local Institution - 0033

Düsseldorf, 40225, Germany

COMPLETED

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Klinikum der Universität München Großhadern

München, 81337, Germany

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Local Institution - 0016

Barcelona, Barcelona [Barcelona], 08035, Spain

NOT YET RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Manchester Royal Infirmary

Manchester, Lancashire, M20 2RZ, United Kingdom

RECRUITING

University College London Hospital

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

RECRUITING

Salford Royal Hospital

Salford, Manchester, M6 8HD, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 1RD, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Sclerosis; Myasthenia Gravis

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 23, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

ES (5); BE (2); FR (2); US (17); DE (5); GB (4)