A Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cells in the Treatment of Refractory Myasthenia Gravis
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 refractory myasthenia gravis, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.
• 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.