RecruitingPhase 1NCT05828225
Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of Refractory Myasthenia Gravis
A Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cells in the Treatment of Refractory Myasthenia Gravis
Sponsor
Zhejiang University
Enrollment
9 participants
Start Date
Apr 30, 2023
Study Type
INTERVENTIONAL
Conditions
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 refractory myasthenia gravis, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- \. Age ≥18 and gender unlimited；
- \. 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;
- \. Consistent with the clinical classification of MGFA myasthenia gravis IIa-IVb (including IIa，IIb，IIIa， IIIb， IVa，IVb)
- \. The baseline MG-ADL score ≥5 and the musculi oculi related score< 50 ；
- \. Baseline QMG score>11;
- \. 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；
- \. The estimated survival time is more than 12 weeks;
- \. 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 Criteria13
- \. Epilepsy history or other central nervous system disease;
- \. 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 ;
- \. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm 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-stimulation signal;
- \. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0 mg /dl;
- \. Those who suffer from other uncontrolled diseases are not suitable to join the study;
- \. HIV infection;
- \. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
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Interventions
DRUGCD19 CAR-T cells injection
CD19 CAR-T in the Treatment of Refractory Myasthenia Gravis
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05828225
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