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

NCT07021209 | Recruiting Phase 1

• 1 other identifier: GRIT-CD-CHN-719-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neurological Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adversed events

  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

  24 months

Secondary Outcomes (1)

• Pharmacokinetics of GT719 cells

  24 months

Study Arms (1)

GT719 Injection treatment group

EXPERIMENTAL

GT719 Injection

Biological: GT719 Injection

Interventions

GT719 Injection BIOLOGICAL

GT719 Injection

GT719 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Grit Biotechnology: lead
• Tongji Hospital: collaborator

Study Sites (1)

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

Wuhan, Hubei, China

RECRUITING

Study Officials

• Wei Wang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Daishi Tian

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Chuan Qin

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daishi Tian

CONTACT

+8613607178809; tiands@tjh.tjmu.edu.cn

Wei Wang

CONTACT

+86-27-83662640; wwang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 13, 2025
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 13, 2028
• Study Completion (Estimated): January 13, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)