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Recruiting
NCT07021209
GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases
Conditions: Neurological Autoimmune Diseases
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Grit Biotechnology
Location: Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Summary
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.
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.
Source: ClinicalTrials.gov (NCT07021209). StuddyBuddy aggregates publicly available trial information.