NCT06220201Active, not recruitingPhase 1
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).
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- 28 Mar 2024
- Primary completion date
- 15 Jul 2027
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Diseases
- Myasthenia gravis, Multiple sclerosis
- NCT number
- NCT06220201
- EudraCT number
- 2023-507820-22
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 120
- From 28 Mar 2024 to the primary completion date, 15 Jul 2027
- 34 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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
- Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \< 150 seconds.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- \- 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).
- \- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitaetsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Universitaetsklinikum - Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitaetsklinikum Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Unknown status |
| Klinikum der Universität München-Großhadern Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hopital Claude Huriez - CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Pitié-Salpêtrière University Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Mellen Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Neurological Institute of New York Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Yale-New Haven Hospital Coordinator of this site? Confirm its status | North Haven | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.