Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07021209

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

Led by Grit Biotechnology · Updated on 2025-09-15

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

G

Grit Biotechnology

Lead Sponsor

T

Tongji Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily enrolled in the study and signed an informed consent form
  • Willing and able to follow the study protocol
  • Expected to survive more than 12 weeks
  • Completed any previous systemic treatment at least 4 weeks or 5 half lives before planned treatment
Not Eligible

You will not qualify if you...

  • History of organ transplantation, splenectomy, or stem cell transplantation
  • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment requiring systemic anticoagulant therapy
  • Received systemic corticosteroids at a dose of at least 10 mg/day prednisone equivalent within 7 days before GT719 infusion, except inhaled corticosteroids

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Actively Recruiting

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Research Team

D

Daishi Tian

CONTACT

W

Wei Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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