RecruitingPhase 1NCT07021209
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
Sponsor
Grit Biotechnology
Enrollment
30 participants
Start Date
Jan 14, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria3
- 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 Criteria3
- 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.
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Interventions
BIOLOGICALGT719 Injection
GT719 Injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07021209