GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases

A Single-arm, Open-label, Phase I Clinical Study of GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases

This study is an open-label, prospective, exploratory clinical trial that includes a dose escalation phase and a dose expansion phase, aimed at evaluating the safety, cell dynamics, and preliminary efficacy of GT719 cells in adult participants with recurrent/refractory antibody-mediated neurological immune diseases.

Inclusion Criteria:

• Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
• Expected survival period>12 weeks.
• Any previous systemic treatment must have undergone at least 4 weeks or 5 half lives (whichever is shorter) by the time the participant plans to receive the study treatment.

Exclusion Criteria:

• History of organ transplantation, splenectomy, and allogeneic or autologous stem cell transplantation.
• History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
• Received systemic corticosteroids at a dose of ≥10 mg/day prednisone equivalent within 7 days prior to GT719 infusion, except for inhaled corticosteroids.