OncoMatch/Clinical Trials/NCT05828225
Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of Refractory Myasthenia Gravis
Is NCT05828225 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD19 CAR-T cells for myasthenia gravis.
Treatment: CD19 CAR-T cells — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CHRNA1 antibody positive
AchR antibody positive
Prior therapy
Must have received: corticosteroid (conventional hormones)
recurrence or exacerbation after treatment with conventional hormones
Must have received: immunosuppressant (azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide)
recurrence or exacerbation after treatment with immunosuppressants (such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, etc.)
Must have received: anti-CD20 therapy (rituximab)
recurrence or exacerbation after treatment with ... rituximab
Cannot have received: gene therapy
Those who have used any gene therapy products before
Lab requirements
Kidney function
Serum creatinine > 2.5mg/dl [excluded]
Liver function
ALT / AST > 3 times ULN or bilirubin > 2.0 mg/dl [excluded]
Cardiac function
Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past [excluded]
Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0 mg/dl; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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