GT719 Injection for Recurrent/Refractory Antibody Mediated Systemic Immune Diseases

Phase 1

Recruiting

• Conditions: Neurological Disorder
• Interventions: Biological: GT719 Injection

• Registration Number: NCT07021209
• Lead Sponsor: Grit Biotechnology

Brief 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 disorders.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-14
• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-15
• Primary Completion: 2028-01-13
• Study Completion: 2028-01-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 within 7 days prior to GT719 infusion, except for inhaled corticosteroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT719 Injection treatment group	GT719 Injection	GT719 Injection

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adversed events	3 years	To characterize the safety profile of GT719 in patients with recurrent/refractory antibody-mediated neurological immune disorders as measured by the incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of GT719 cells	3 years	Survival time of GT719 cells after infusion of GT719 Injection

Trial Locations

Locations (1)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China