Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507820-22 | Other Identifier | EU CT Number | |
| U1111-1296-8579 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC-97540 (RMS arm) | Experimental |
| |
| Administration of CC-97540 (PMS arm) | Experimental |
| |
| Administration of CC-97540 (MG arm) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-97540 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | For Cohorts 1 and 2 | Up to week 104 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants meeting no evidence of disease activity (NEDA) criteria | Up to week 104 | |
| Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS) | Up to week 12 |
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0011 | Active, not recruiting | Birmingham | Alabama | 35294 | United States | |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
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
See Plan Description
See Plan Description
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fludarabine | Drug | Specified dose on specified days |
|
| Cyclophosphamide | Drug | Specified dose on specified days |
|
| Annualized relapse rate | Up to week 104 |
| 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 | Up to week 104 |
| Number of participants with disability improvement confirmed per EDSS | Up to week 12 |
| Maximum observed blood concentration (Cmax) | Up to week 104 |
| Time of maximum observed blood concentration (Tmax) | Up to week 104 |
| Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) | Up to week 104 |
| Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast) | Up to week 104 |
| 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 | Up to week 26 |
| Number of participants with at least 3 point improvement in Myasthenia Gravis composite (MG-C) score | For Cohort 3 | Up to week 26 |
| Number of participants with at least 3 point improvement in quantitative Myasthenia Gravis (QMG) score | For Cohort 3 | Up to week 26 |
| University of California, Irvine |
| Recruiting |
| Irvine |
| California |
| 92697 |
| United States |
|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
|
| Yale-New Haven Hospital | Recruiting | North Haven | Connecticut | 06473 | United States |
|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| Local Institution - 0039 | Withdrawn | New Orleans | Louisiana | 70121 | United States |
| Local Institution - 0005 | Completed | Boston | Massachusetts | 02114 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Neurological Institute of New York | Recruiting | New York | New York | 10032 | United States |
|
| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| Cleveland Clinic Mellen Center | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| Swedish Medical Center | Recruiting | Seattle | Washington | 98122 | United States |
|
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| Antwerp University Hospital | Recruiting | Edegem | Antwerpen | 2650 | Belgium |
|
| UZ Gent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
|
| Hopital Claude Huriez - CHU de Lille | Recruiting | Lille | Nord | 59000 | France |
|
| Pitie Salpetriere University Hospital | Recruiting | Paris | Ville de Paris | 75013 | France |
|
| Universitaetsklinikum Essen | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
|
| Universitaetsklinikum Magdeburg | Recruiting | Magdeburg | Saxony-Anhalt | 39120 | Germany |
|
| Local Institution - 0033 | Completed | Düsseldorf | 40225 | Germany |
| Universitaetsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
|
| Klinikum der Universität München Großhadern | Recruiting | München | 81337 | Germany |
|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
|
| Local Institution - 0016 | Not yet recruiting | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Catalunya [Cataluña] | 08036 | Spain |
|
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Madrid, Comunidad de | 28034 | Spain |
|
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
|
| Manchester Royal Infirmary | Recruiting | Manchester | Lancashire | M20 2RZ | United Kingdom |
|
| University College London Hospital | Recruiting | London | London, City of | NW1 2PG | United Kingdom |
|
| Salford Royal Hospital | Recruiting | Salford | Manchester | M6 8HD | United Kingdom |
|
| Barts Health NHS Trust | Recruiting | London | E1 1RD | United Kingdom |
|
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided