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

Phase 1

Recruiting

• Conditions: Neurological Autoimmune Diseases
• 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 diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-14
• Study First Submitted: 2025-05-29
• Study First Submitted QC: 2025-06-06
• Study First Posted: 2025-06-13
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-15
• Primary Completion: 2028-01-13
• Study Completion: 2028-01-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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	24 months	To characterize the safety profile of GT719 in patients with recurrent/refractory antibody-mediated neurological immune diseases as measured by the incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of GT719 cells	24 months	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