Experimental CAR-T therapy targets devastating nerve disease
NCT ID NCT07592754
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new treatment called KSVCBD, a type of CAR-T cell therapy, for people with a severe autoimmune disease called neuromyelitis optica spectrum disorder (NMOSD) that has not responded to standard treatments. The study will include 18 adults who test positive for AQP4 antibodies and have had at least one relapse in the past year. The main goal is to check the safety of the therapy and see if it can reduce relapses and disability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies. 2. Documented evidence of at least 1 relapse within 12 months before signing the informed consent form. 3. The Expanded Disability Status Scale (EDSS) score ≤ 8. 4. Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period. 5. Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided. Key Exclusion Criteria: 1. Viral infections: Known HIV, active HBV, or active HCV. 2. Pregnant or breastfeeding women. 3. History of other autoimmune diseases requiring immunosuppressive therapy. 4. Use of any live vaccines against infectious disease within 6 weeks before enrollment. 5. History of bone marrow/hematopoietic stem cell or solid organ transplantation. 6. Patients deemed unsuitable for participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
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