Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of R/R Neuromyelitis Optica

Korábbi kezelés

• 6. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
• 7. Those who have used any gene therapy products before;

Más betegség

• 1. Epilepsy history or other central nervous system disease;
• 4. Patients with severe active infections;
• 5. Active infection of hepatitis B virus or hepatitis C virus;
• 10. Those who suffer from other uncontrolled diseases are not suitable to join the study;
• 11. HIV infection;

Laborértékek

• 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past;
• 9. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;

Egyéb

• 3. Pregnant (or lactating) women;
• 8. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 12. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

• 1. Age 18-60 and gender unlimited;
• 2. NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria;
• 3. Diagnostic criteria for AQP4-IgG positive NMOSD Diagnostic criteria for AQP4-IgG positive NMOSD
  • At least 1 core clinical feature
  • Using reliable methods to detect positive AQP4-IgG (CBA method)
  • Exclude other diagnoses. Core clinical features
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  • Acute myelitis
  • Posterior region syndrome, unexplained paroxysmal hiccup, nausea, and vomiting
  • Other brainstem syndromes
  • Symptomatic episodic sleeping sickness, diencephalic syndrome, brain MRI with NMOSD characteristic diencephalic lesions
  • Cerebral syndrome with NMOSD characteristic brain lesions
• 4. Corticosteroids combined with immunosuppressants (azathioprine or mycophenolate mofetil or rituximab) still relapse after treatment；
• 5. At least 2 relapses within the past 12 months or at least 3 relapses within the past 24 months, and at least 1 recurrence within the 12 months prior to screening；
• 6. The estimated survival time is more than 12 weeks;
• 7. Women of childbearing age who have negative urine pregnancy test before medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up