NCT07021209 GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases
| NCT ID | NCT07021209 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Grit Biotechnology |
| Condition | Neurological Autoimmune Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-14 |
| Primary Completion | 2028-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-01-14 with a primary completion date of 2028-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Wei Wang
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT07021209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Neurological Autoimmune Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07021209 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07021209 currently recruiting?
Yes, NCT07021209 is actively recruiting participants. Contact the research team at tiands@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT07021209 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07021209 clinical trial?
NCT07021209 is sponsored by Grit Biotechnology. The principal investigator is Wei Wang at Tongji Hospital. The trial plans to enroll 30 participants.