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

Recruiting now · Phase 1

Conditions studied: Neurological Autoimmune Diseases

In brief

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.

Key facts

Study ID

NCT07021209

Run by

Grit Biotechnology

People needed

30

Starts

2025-01-14

Expected to finish

2028-01-13

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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