A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07573332
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • AQP4+ NMOSD

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • CC-97540 (BMS-986353) — BIOLOGICAL
    CD19 CAR T therapy
  • Fludarabine — DRUG
    Lymphodepleting Chemotherapy
  • Cyclophosphamide — DRUG
    Lymphodepleting Chemotherapy
  • Tocilizumab — DRUG
    management of CRS

Study Details

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

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Aug 1, 2030
Completion
Aug 1, 2031

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants who are AQP4 antibody-positive NMOSD treated with CC-97540 (BMS- 986353)

Primary Outcome Measure

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 [ Time Frame: From infusion to 52 weeks post-infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT SouthwesternDallasTexas75390
Manuel Huichapa
[email protected]
214-645-8216

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By research site
UT Southwestern· Dallas, TX

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