RECRUITINGPhase 1INTERVENTIONAL
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).
About This Trial
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).
Who May Be Eligible (Plain English)
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
CC-97540
Specified dose on specified days
DRUG
Fludarabine
Specified dose on specified days
DRUG
Cyclophosphamide
Specified dose on specified days
Locations (20)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Irvine
Irvine, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Local Institution - 0039
New Orleans, Louisiana, United States
Local Institution - 0005
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Neurological Institute of New York
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Mellen Center
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Swedish Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Antwerp University Hospital
Edegem, Antwerpen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France