GT719 injection for recurrent or refractory antibody-mediated neurological autoimmune disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.