CC-97540
DrugSpecified dose on specified days
Other names: BMS-986353
NCT Number: NCT06220201
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).
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1
Antwerp University Hospital, Edegem, Antwerpen, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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).
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
Specified dose on specified days
Other names: BMS-986353
Specified dose on specified days
Specified dose on specified days
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 104
For Cohorts 1 and 2
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 12
Time frame: Up to week 104
Time frame: Up to week 104
MRI metrics assessed are 1) number of gadolinium-enhancing T1 lesions and 2) total number of new or enlarging hyperintense T2-weigted lesions
Time frame: Up to week 12
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 104
Time frame: Up to week 26
For Cohort 3
Time frame: Up to week 26
For Cohort 3
Time frame: Up to week 26
For Cohort 3
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Industry
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).
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07304154
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Palo Alto, California, United States
View Trial DetailsNCT07653984
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Guangzhou, Guangdong, China
View Trial DetailsNCT06939166
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Tianjin, China
View Trial DetailsNCT06940323
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
San Francisco, California, United States
View Trial Details