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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- 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 — Up to week 104
For Cohorts 1 and 2 - 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
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in Spain
Other trials for the same condition
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 Spain