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

NCT ID: NCT07021209

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-14

Study Completion Date

2028-01-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurological Autoimmune Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GT719 Injection treatment group

GT719 Injection

Group Type EXPERIMENTAL

GT719 Injection

Intervention Type BIOLOGICAL

GT719 Injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GT719 Injection

GT719 Injection

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tongji Hospital

OTHER

Sponsor Role collaborator

Grit Biotechnology

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wei Wang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Daishi Tian

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Chuan Qin

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daishi Tian

Role: CONTACT

+8613607178809

Wei Wang

Role: CONTACT

+86-27-83662640

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daishi Tian

Role: primary

+8613607178809

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GRIT-CD-CHN-719-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

GC012F in Patients With Autoimmune Diseases
NCT07072884 NOT_YET_RECRUITING EARLY_PHASE1