Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of Refractory Myasthenia Gravis
Myasthenia Gravis
About this trial
This is an interventional treatment trial for Myasthenia Gravis
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 and gender unlimited; 2. Confirmed as refractory myasthenia gravis with AchR antibody positive and accord one of the following three conditions Repeated electrical stimulation suggests neuromuscular conduction deficits; Tensilon test and neostigmine test positive; The doctor judged that the symptoms of MG improved after treatment with oral cholinease inhibitors; 3. Consistent with the clinical classification of MGFA myasthenia gravis IIa-IVb (including IIa,IIb,IIIa, IIIb, IVa,IVb) 4. The baseline MG-ADL score ≥5 and the musculi oculi related score< 50 ; 5. Baseline QMG score>11; 6. Regular treatment with poor efficacy and/or lack of effective treatment means that there is still recurrence or exacerbation after treatment with conventional hormones, immunosuppressants (such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, etc.) or rituximab; 7. The estimated survival time is more than 12 weeks; 8. 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. Exclusion Criteria: 1. Epilepsy history or other central nervous system disease; 2. During the screening visit, the patient's thymectomy was less than 12 months or thymectomy was necessary during the study period or thymic radiation therapy ; 3. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past; 4. Pregnant (or lactating) women; 5. Patients with severe active infections; 6. Active infection of hepatitis B virus or hepatitis C virus; 7. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids); 8. Those who have used any gene therapy products before; 9. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 10. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0 mg /dl; 11. Those who suffer from other uncontrolled diseases are not suitable to join the study; 12. HIV infection; 13. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Sites / Locations
- The first affiliated hospital of medical college of zhejiang universityRecruiting
Arms of the Study
Arm 1
Experimental
Treatment Group
Myasthenia Gravis