A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive N… (NCT07573332) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients
United States5 participantsStarted 2026-06-01
Plain-language summary
The goal of this clinical trial is to find out if the investigational medicine BMS-986353 is safe and well tolerated in adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a long-term autoimmune condition that affects the optic nerves and spinal cord and can lead to relapses. Most people with NMOSD have antibodies against AQP4, which are linked to future disease activity.
The main questions this study aims to answer are:
"-" Is CC-97540 (BMS-986353) safe and well tolerated, based on how many participants experience serious side effects that limit dosing (called dose-limiting toxicities)?
"-" Does CC-97540 (BMS-986353) show early signs of benefit, based on how many participants no longer have detectable AQP4 antibodies in their blood (called sero-reversion)?
Participants are adults aged 18 to 60 years with AQP4 antibody-positive NMOSD who are currently clinically stable on ravulizumab or satralizumab. Approved NMOSD treatments reduce relapses by changing how the immune system works, but they do not remove the cells that make AQP4 antibodies. This study is designed to see whether BMS-986353 can target these cells without the need for long-term immune suppression.
Participants will:
"-" Receive CC-97540 (BMS-986353) as part of the study "-" Continue their current NMOSD therapy "-" Attend study visits for safety checks, exams, and lab tests
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent
✓. Age 18 to 60 inclusive
✓. Diagnosis of anti-AQP4 antibody positive NMOSD by 2015 Wingerchuk IPND criteria
✓. No relapses within last 12 months
✓. Stable ravulizumab or satralizumab dosing for at least 6 months
✓. Up to date on meningococcal vaccines and enrolled in any required REMS program
✓. EDSS score of 6.5 or less
✓. At least one eye best visual acuity 20/200 or better
Exclusion criteria
✕. History of active meningococcal disease
✕. Presence of active, clinically significant concomitant CNS pathology, other than NMOSD, that may confound the ability to interpret study results, including but not limited to, seizure disorder, traumatic brain injuries, delirium, Parkinson's disease, psychosis, Neuro-Behcet's disease, Guillain-Barré syndrome, metabolic or infectious cause of myelopathy, genetically-inherited progressive CNS disorder, ischemic cerebrovascular disorders, including, but not limited to, transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage; CNS sarcoidosis; history of anti- myelin oligodendrocyte glycoprotein antibody-associated disorder or a diagnosis of progressive multifocal leukoencephalopathy (PML) or history of PML; or of infectious or autoimmune encephalitis or meningitis under prior DMT.
What they're measuring
1
To evaluate the safety and tolerability of CC-97540 (BMS-986353) in participants with anti-AQP4 antibody positive NMO as determined by the proportion of patients experiencing DLTs
Timeframe: From infusion to 52 weeks post-infusion
2
To evaluate the preliminary efficacy of CC-97540 (BMS-986353) in participants with anti-AQP4 antibody positive NMO as determined by the proportion of patients who sero-revert.
Timeframe: From infusion to 6 months post-infusion
Trial details
NCT IDNCT07573332
SponsorUniversity of Texas Southwestern Medical Center
✕. Any significant medical condition, laboratory test abnormality or psychiatric Active infection requiring treatment
✕. Hypersensitivity or allergy to fludarabine, cyclophosphamide, excipients of CC- 97540, ravulizumab, tocilizumab or satralizumab.
✕. condition that would pose a risk the participant's safety from participating in the study.
✕. Active autoimmune condition other than NMOSD that requires immunotherapy
✕. History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina, angioplasty or stenting, or other clinically significant cardiac disease.
✕. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the investigator; or unwillingness or inability to follow the procedures required in the protocol.