NCT07592754Not yet recruitingEarly phase 1
The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.
An Early Exploratory Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of Relapsed/Refractory AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder.
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This is a multi-center, single-arm, open-label, early exploratory clinical study. The objective of this study is to evaluate the safety and preliminary efficacy of KSVCBD injection in AQP4-positive Neuromyelitis Optica Spectrum Disorder
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 12 May 2026
- Start date
- 15 May 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT07592754
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 18
- From 15 May 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any live vaccines against infectious disease within 6 weeks before enrollment.
Other illness
- Viral infections: Known HIV, active HBV, or active HCV.
- History of other autoimmune diseases requiring immunosuppressive therapy.
- History of bone marrow/hematopoietic stem cell or solid organ transplantation.
Other
- Pregnant or breastfeeding women.
- Patients deemed unsuitable for participation by the investigator.
Who the study is looking for
- Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies.
- Documented evidence of at least 1 relapse within 12 months before signing the informed consent form.
- The Expanded Disability Status Scale (EDSS) score ≤ 8.
- Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period.
- Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.