GT719 injection for recurrent or refractory antibody-mediated neurological autoimmune disease
A Single-arm, Open-label, Phase I Clinical Study of GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases
This trial will try an experimental cell therapy called GT719 in adults with recurrent or treatment-resistant antibody-mediated neurological autoimmune diseases to see if it is safe and may help disease activity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07021209 on ClinicalTrials.gov |
What this trial studies
This is an open-label, prospective Phase 1 trial with a dose-escalation stage followed by a dose-expansion stage to test GT719 cell injections in adults with recurrent or refractory antibody-mediated neurological autoimmune conditions. The primary focus is safety and tolerability, with secondary exploration of cell dynamics and early signs of clinical benefit. Participants must meet survival and washout criteria and will be closely monitored after infusion for adverse events and immune responses. The trial is conducted at a single site in Wuhan, China, under collaboration between the sponsor and a tertiary hospital.
Who should consider this trial
Good fit: Adults with recurrent or refractory antibody-mediated neurological autoimmune diseases who can consent, have expected survival over 12 weeks, and have completed required washout periods from prior systemic treatments are ideal candidates.
Not a fit: Patients with prior organ or stem-cell transplants, recent symptomatic deep vein thrombosis or pulmonary embolism requiring anticoagulation, or those on recent high-dose systemic corticosteroids are unlikely to be eligible and may not benefit from participation.
Why it matters
Potential benefit: If successful, GT719 could offer a new cell-based treatment option that reduces relapses or symptoms in patients who have not responded to standard therapies.
How similar studies have performed: Some other cell-based and immune-targeting therapies (for example autologous HSCT or targeted B-cell therapies) have shown promise in certain autoimmune neurological disorders, but GT719 represents a novel investigational approach with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Wei Wang — Tongji Hospital
- Study coordinator: Daishi Tian
- Email: tiands@tjh.tjmu.edu.cn
- Phone: +8613607178809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.