eligibility_summary
Adults ≥18 with refractory AChR+ MG: MGFA IIa–IVb, MG‑ADL ≥5, QMG >11, confirmed by RNS/Tensilon/neostigmine or ChEI response, inadequate response/relapse on standard therapy, survival >12 wks, WOCBP: negative test, contraception. Exclude CNS disease, thymectomy <12 mo/needed or thymic RT, QT/serious heart disease, pregnancy/lactation, active infection (HBV/HCV/HIV), systemic steroids <4 wks, prior gene therapy, poor CD3/CD28 proliferation, renal/hepatic dysfunction, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19 CAR‑T cells injection—an autologous, genetically engineered T‑cell therapy (cell-based immunotherapy) expressing a chimeric antigen receptor targeting CD19. Mechanism of action: CAR‑T cells bind and kill CD19+ B cells/plasmablasts, leading to B‑cell depletion and reduction of pathogenic anti–acetylcholine receptor (AChR) autoantibodies that drive myasthenia gravis. Cells/pathways targeted: CD19-expressing B‑lineage cells (naive, memory B cells, plasmablasts), humoral/autoantibody-mediated immune pathway affecting the neuromuscular junction (AChR). Trial design: single‑arm, open‑label phase 1 in refractory AChR+ MG, assessing safety and CAR‑T pharmacokinetics.