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Multiple SclerosisPhase 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 study testing CC-97540, Fludarabine and Cyclophosphamide in people with Multiple Sclerosis and Myasthenia Gravis, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 34 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis, Myasthenia Gravis
What is being tested?
CC-97540, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
34 sitesin 6 countries
Study dates
28 Mar 2024to 15 Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 6 countries.

34 sites in 6 countries

United States16 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Local Institution - 0011

    Birmingham, Alabama, 35294

  • Local Institution - 0005

    Boston, Massachusetts, 02114

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Mellen Center

    Cleveland, Ohio, 44195

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of California, Irvine

    Irvine, California, 92697

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Neurological Institute of New York

    New York, New York, 10032

  • Yale-New Haven Hospital

    North Haven, Connecticut, 06473

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Germany5 sites

  • Local Institution - 0033

    Düsseldorf, 40225

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Universitaetsklinikum Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

  • Klinikum der Universität München Großhadern

    München, 81337

Other trials in Germany

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

  • Local Institution - 0016

    Barcelona, Barcelona [Barcelona], 08035

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

United Kingdom4 sites

  • University College London Hospital

    London, London, City of, NW1 2PG

  • Barts Health NHS Trust

    London, E1 1RD

  • Manchester Royal Infirmary

    Manchester, Lancashire, M20 2RZ

  • Salford Royal Hospital

    Salford, Manchester, M6 8HD

Other trials in United Kingdom

Belgium2 sites

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

France2 sites

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord, 59000

  • Pitie Salpetriere University Hospital

    Paris, Ville de Paris, 75013

Other trials in France

About this study

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).

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).

Being tested
CC-97540, Fludarabine, Cyclophosphamide
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
Medical subject headings
Multiple Sclerosis, Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-97540Drug

    Also called BMS-986353

    Specified dose on specified days

  • FludarabineDrug

    Specified dose on specified days

  • CyclophosphamideDrug

    Specified dose on specified days

Study groups in NCT06220201
Study groupRoleWhat they receive
Administration of CC-97540 (RMS arm)ExperimentalNot described
Receives: Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide
Administration of CC-97540 (PMS arm)ExperimentalNot described
Receives: Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide
Administration of CC-97540 (MG arm)ExperimentalNot described
Receives: Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    Measured: Up to week 104

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

    Measured: Up to week 104

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

    Measured: Up to week 104

  4. Number of participants with laboratory test result abnormalities

    Measured: Up to week 104

  5. Number of participants with imaging abnormalities

    For Cohorts 1 and 2

    Measured: Up to week 104

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

    Measured: Up to week 104

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

    Measured: Up to week 104

Secondary outcomes (12)

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

    Measured: Up to week 104

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

    Measured: Up to week 12

  3. Annualized relapse rate

    Measured: Up to week 104

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

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

    Measured: Up to week 104

  5. Number of participants with disability improvement confirmed per EDSS

    Measured: Up to week 12

  6. Maximum observed blood concentration (Cmax)

    Measured: Up to week 104

  7. Time of maximum observed blood concentration (Tmax)

    Measured: Up to week 104

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

    Measured: Up to week 104

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

    Measured: 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

    For Cohort 3

    Measured: Up to week 26

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

    For Cohort 3

    Measured: Up to week 26

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

    For Cohort 3

    Measured: Up to week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start28 Mar 2024
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220201
Sponsor's protocol ID
CA061-1006
Other IDs
2023-507820-22, U1111-1296-8579, 2023
Status last verified
Jul 2026
First submitted
4 Jan 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-97540, Fludarabine and Cyclophosphamide in people with Multiple Sclerosis and Myasthenia Gravis, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 34 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Germany, Spain, United Kingdom, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Up to week 104). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06220201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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Clinical Trial NCT06220201 | AzTrials