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NCT Number: NCT06220201

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)

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Antwerp University Hospital, Edegem, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC-97540

Drug

Specified dose on specified days

Other names: BMS-986353

Fludarabine

Drug

Specified dose on specified days

Cyclophosphamide

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to week 104

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to week 104

  3. Number of participants with adverse events of special interest (AESIs)

    Time frame: Up to week 104

  4. Number of participants with laboratory test result abnormalities

    Time frame: Up to week 104

  5. Number of participants with imaging abnormalities

    Time frame: Up to week 104

    For Cohorts 1 and 2

  6. Number of participants with dose-limiting toxicities (DLTs)

    Time frame: Up to week 104

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

    Time frame: Up to week 104

Secondary outcomes

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

    Time frame: Up to week 104

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

    Time frame: Up to week 12

  3. Annualized relapse rate

    Time frame: Up to week 104

  4. Change from baseline in magnetic resonance imaging (MRI) metrics

    Time frame: Up to week 104

    MRI metrics assessed are 1) number of gadolinium-enhancing T1 lesions and 2) total number of new or enlarging hyperintense T2-weigted lesions

  5. Number of participants with disability improvement confirmed per EDSS

    Time frame: Up to week 12

  6. Maximum observed blood concentration (Cmax)

    Time frame: Up to week 104

  7. Time of maximum observed blood concentration (Tmax)

    Time frame: Up to week 104

  8. Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

    Time frame: Up to week 104

  9. Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast)

    Time frame: Up to week 104

  10. Number of participants with at least 2 points improvement for at least 4 weeks in Myasthenia Gravis activities of daily living (MG-ADL) score

    Time frame: Up to week 26

    For Cohort 3

  11. Number of participants with at least 3 point improvement in Myasthenia Gravis composite (MG-C) score

    Time frame: Up to week 26

    For Cohort 3

  12. Number of participants with at least 3 point improvement in quantitative Myasthenia Gravis (QMG) score

    Time frame: Up to week 26

    For Cohort 3

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Celgene Corporation

Registry information

Official study 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).

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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