Neurological Autoimmune Diseases
Conditions
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.
Interventions
BIOLOGICALGT719 Injection
GT719 Injection
Sponsors
Grit Biotechnology
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adversed events | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of GT719 cells | 24 months | Survival time of GT719 cells after infusion of GT719 Injection |
Countries
China
Contacts
CONTACTDaishi Tian
CONTACTWei Wang
PRINCIPAL_INVESTIGATORWei Wang
Tongji Hospital
PRINCIPAL_INVESTIGATORDaishi Tian
Tongji Hospital
PRINCIPAL_INVESTIGATORChuan Qin
Tongji Hospital
Outcome results
None listed