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).
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• \- 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.
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
University of California, Irvine
RECRUITING
Irvine
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Colorado Blood Cancer Institute
RECRUITING
Denver
Connecticut
Yale-New Haven Hospital
RECRUITING
New Haven
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Louisiana
Local Institution - 0039
WITHDRAWN
New Orleans
Massachusetts
Local Institution - 0005
COMPLETED
Boston
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Neurological Institute of New York
RECRUITING
New York
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Mellen Center
RECRUITING
Cleveland
Oregon
Local Institution - 0037
NOT_YET_RECRUITING
Portland
Washington
Swedish Medical Center
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Belgium
Antwerp University Hospital
RECRUITING
Edegem
UZ Gent
RECRUITING
Ghent
France
Hopital Claude Huriez - CHU de Lille
RECRUITING
Lille
Pitie Salpetriere University Hospital
RECRUITING
Paris
Germany
Universitaetsklinikum Duesseldorf
RECRUITING
Düsseldorf
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Universitaetsklinikum Essen
RECRUITING
Essen
Klinikum der Universität München Großhadern
RECRUITING
München
Italy
Local Institution - 0008
WITHDRAWN
Milan
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Local Institution - 0016
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
United Kingdom
Barts Health NHS Trust
RECRUITING
London
University College London Hospital
RECRUITING
London
Manchester Royal Infirmary
RECRUITING
Manchester
Salford Royal Hospital
RECRUITING
Salford
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date:2024-03-28
Estimated Completion Date:2027-07-15
Participants
Target number of participants:120
Treatments
Experimental: Administration of CC-97540 (RMS arm)
Experimental: Administration of CC-97540 (PMS arm)