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NCT07573332 · ClinicalTrials.gov registry record · Phase 1
A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT07573332: Clinical Trial Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT07573332 is a Phase 1 study that has not yet begun recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07573332, a Phase 1 study, has not yet begun recruiting, sponsored by University of Texas Southwestern Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study 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
Primary Outcome
Proportion of patients experiencing DLTs at 4, 12 and 52 weeks post- infusion with CC-97540 (BMS-986353)
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Tocilizumab
- BIOLOGICAL CC-97540 (BMS-986353)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2031-08-01 |
| Phase | Phase 1 |
What is known before NCT07573332 opens enrollment
NCT07573332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT07573332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07573332 about?
NCT07573332 is a clinical study titled "A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients". 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 sp...
What is the current status of trial NCT07573332?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2026-06-01. Estimated completion is 2031-08-01.
What interventions are being tested in trial NCT07573332?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Tocilizumab (DRUG), CC-97540 (BMS-986353) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07573332?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07573332's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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