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

Last updated: April 12, 2023
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT05828212
TXB2023005
  • Ages 18-60
  • All Genders

Study Summary

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with relapsed or refractory Neuromyelitis Optica, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Age 18-60 and gender unlimited;
    1. NMOSD diagnosed based on the 2015 NMOSD International Consensus DiagnosticCriteria;
    1. Diagnostic criteria for AQP4-IgG positive NMOSD Diagnostic criteria for AQP4-IgGpositive NMOSD
  1. At least 1 core clinical feature
  2. Using reliable methods to detect positive AQP4-IgG (CBA method)
  3. Exclude other diagnoses. Core clinical features
  4. ON
  5. Acute myelitis
  6. Posterior region syndrome, unexplained paroxysmal hiccup, nausea, and vomiting
  7. Other brainstem syndromes
  8. Symptomatic episodic sleeping sickness, diencephalic syndrome, brain MRI withNMOSD characteristic diencephalic lesions
  9. Cerebral syndrome with NMOSD characteristic brain lesions
    1. Corticosteroids combined with immunosuppressants (azathioprine or mycophenolatemofetil or rituximab) still relapse after treatment;
    1. 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;
    1. The estimated survival time is more than 12 weeks;
    1. 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:

    1. Epilepsy history or other central nervous system disease;
    1. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythm ia in the past;
    1. Pregnant (or lactating) women;
    1. Patients with severe active infections;
    1. Active infection of hepatitis B virus or hepatitis C virus;
    1. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
    1. Those who have used any gene therapy products before;
    1. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulationsignal;
    1. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
    1. Those who suffer from other uncontrolled diseases are not suitable to join thestudy;
    1. HIV infection;
    1. 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
    China

    Active - Recruiting

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