OncoMatch

OncoMatch/Clinical Trials/NCT06371040

Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis

Is NCT06371040 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CD19-BCMA Targeted CAR-T Dose 1 and CD19-BCMA Targeted CAR-T Dose 2 for myasthenia gravis.

Phase 1RecruitingTing Chang, MDNCT06371040Data as of May 2026

Treatment: CD19-BCMA Targeted CAR-T Dose 1 · CD19-BCMA Targeted CAR-T Dose 2 · CD19-BCMA Targeted CAR-T Dose 2This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited.

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Extracted eligibility criteria

Prior therapy

Min 2 prior lines

Must have received: immunosuppressant

Treatment failed after receiving at least 2 immunosuppressants

Cannot have received: rituximab (rituximab)

received rituximab treatment within 6 months before screening

Cannot have received: tocilizumab (tocilizumab)

received tocilizumab ... within 3 months before screening

Cannot have received: eculizumab (eculizumab)

received ... eculizumab treatment within 3 months before screening

Cannot have received: intravenous human immunoglobulin

received intravenous human immunoglobulin ... within 4 weeks before screening

Cannot have received: plasma exchange

received ... plasma exchange ... within 4 weeks before screening

Cannot have received: immunotherapy

received ... immunotherapy within 4 weeks before screening

Lab requirements

Blood counts

Neutrophil count < 1000/ul, Platelet count < 50000/mm3, Hemoglobin < 8.0g/dl excluded

Kidney function

eGFR < 45 mL/min/1.73 m2 excluded

Liver function

AST or ALT > 3x ULN, total bilirubin > 1.5x ULN excluded

Elevated liver enzymes (AST or ALT > 3x ULN). Total bilirubin >1.5x ULN. eGFR <45 mL/min/1.73 m2. Abnormal PT or INR, or prolonged APTT >1.5x ULN. Neutrophil count <1000cell/ul. Platelet count <50000/mm3. Hemoglobin<8.0g/dl

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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