Last updated: April 12, 2023
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Multiple Sclerosis
Treatment
N/AClinical Study ID
NCT05828212
TXB2023005
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-60 and gender unlimited;
- NMOSD diagnosed based on the 2015 NMOSD International Consensus DiagnosticCriteria;
- Diagnostic criteria for AQP4-IgG positive NMOSD Diagnostic criteria for AQP4-IgGpositive NMOSD
- At least 1 core clinical feature
- Using reliable methods to detect positive AQP4-IgG (CBA method)
- Exclude other diagnoses. Core clinical features
- ON
- Acute myelitis
- Posterior region syndrome, unexplained paroxysmal hiccup, nausea, and vomiting
- Other brainstem syndromes
- Symptomatic episodic sleeping sickness, diencephalic syndrome, brain MRI withNMOSD characteristic diencephalic lesions
- Cerebral syndrome with NMOSD characteristic brain lesions
- Corticosteroids combined with immunosuppressants (azathioprine or mycophenolatemofetil or rituximab) still relapse after treatment;
- At least 2 relapses within the past 12 months or at least 3 relapses within thepast 24 months, and at least 1 recurrence within the 12 months prior to screening;
- The estimated survival time is more than 12 weeks;
- Women of childbearing age who have negative urine pregnancy test before medicationadministration and agree to take effective contraceptive measures during the trialperiod until the last follow-up
Exclusion
Exclusion Criteria:
- Epilepsy history or other central nervous system disease;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythm ia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections;
- Active infection of hepatitis B virus or hepatitis C virus;
- Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
- Those who have used any gene therapy products before;
- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulationsignal;
- Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- Those who suffer from other uncontrolled diseases are not suitable to join thestudy;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients orinterfere with the test results.
Study Design
Total Participants: 9
Study Start date:
April 30, 2023
Estimated Completion Date:
April 30, 2026
Connect with a study center
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
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