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Recruiting NCT07021209

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

Phase I Interventional Neurological Autoimmune Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GT719 Injection.
Who it may be relevant to
Registry conditions: Neurological Autoimmune Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological GT719 Injection
    GT719 Injection

Primary outcome measures

  • Incidence and severity of adversed events [Time frame: 24 months]
Secondary outcome measures (1)
  • Pharmacokinetics of GT719 cells [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and T — Wuhan

Identifiers

NCT: NCT07021209 · GRIT-CD-CHN-719-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗