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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

CD19-BCMA Targeted CAR-T Dose 1CD19-BCMA Targeted CAR-T Dose 2CD19-BCMA Targeted CAR-T Dose 2

Demographics

Ages ≤ 80

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.

Frequently asked questions

Is NCT06371040 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior rituximab, tocilizumab, eculizumab disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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