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NCT Number: NCT07021209

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

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.

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Key information

Conditions

Neurological Autoimmune Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Wuhan, Hubei, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GT719 Injection

Biological

GT719 Injection

Primary outcomes

  1. Incidence and severity of adversed events

    Time frame: 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 outcomes

  1. Pharmacokinetics of GT719 cells

    Time frame: 24 months

    Survival time of GT719 cells after infusion of GT719 Injection

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Grit Biotechnology

Industry

Collaborators

  • Tongji Hospital

Registry information

Official study title

A Single-arm, Open-label, Phase I Clinical Study of GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 13, 2025
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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