GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases
ConditionNeurological Autoimmune Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGrit Biotechnology
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GT719 Injection
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Grit Biotechnology
Lead sponsor
Tongji Hospital
Collaborator
Source ClinicalTrials.gov