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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Grit Biotechnology • ClinicalTrials.gov ID: NCT07021209

Registry updated: 2026-09-11
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Description

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.

Interventions

  • GT719 Injection (Biological)
    GT719 Injection

Eligibility criteria

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.

Conditions

Neurological Autoimmune Diseases

Locations

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record