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Clinical Trials in the UK / NCT06220201
Active, not recruiting Phase 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)

NCT06220201 · tracked via the Priya Life Science UK tracker
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Phase
Phase 1
Started
2024-03-28
Last updated
2026-08-03

Condition(s) studied

Multiple SclerosisMyasthenia Gravis

Investigational drug(s) / intervention(s)

CC-97540FludarabineCyclophosphamide

CC-97540: Specified dose on specified days

Fludarabine: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Local Institution - 0011 Birmingham Alabama
University of California, Irvine Irvine California
University of Colorado Anschutz Medical Campus Aurora Colorado
Colorado Blood Cancer Institute Denver Colorado
Yale-New Haven Hospital North Haven Connecticut
University of Kansas Medical Center Kansas City Kansas
Local Institution - 0005 Boston Massachusetts
Washington University School of Medicine St Louis Missouri
Hackensack University Medical Center Hackensack New Jersey
Icahn School of Medicine at Mount Sinai New York New York
Neurological Institute of New York New York New York
University of Cincinnati Medical Center Cincinnati Ohio
Cleveland Clinic Mellen Center Cleveland Ohio
Oregon Health and Science University Portland Oregon
Swedish Medical Center Seattle Washington
Medical College of Wisconsin Milwaukee Wisconsin
Antwerp University Hospital Edegem Antwerpen
UZ Gent Ghent Oost-Vlaanderen
Hopital Claude Huriez - CHU de Lille Lille Nord
Pitie Salpetriere University Hospital Paris Ville de Paris
Universitaetsklinikum Essen Essen North Rhine-Westphalia
Universitaetsklinikum Magdeburg Magdeburg Saxony-Anhalt
Local Institution - 0033 Düsseldorf Germany
Universitaetsklinikum Erlangen Erlangen Germany
Klinikum der Universität München Großhadern München Germany
Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona]
Local Institution - 0016 Barcelona Barcelona [Barcelona]
Hospital Clínic de Barcelona Barcelona Catalunya [Cataluña]
Hospital Universitario Ramón y Cajal Madrid Madrid, Comunidad de
Hospital Universitari i Politecnic La Fe Valencia Spain
Manchester Royal Infirmary Manchester Lancashire
University College London Hospital London London, City of
Salford Royal Hospital Salford Manchester
Barts Health NHS Trust London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06220201 on ClinicalTrials.gov ↗ ← All trials in the UK