GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases

Grit Biotechnology

Status and phase

Enrolling

Phase 1

Conditions

Neurological Autoimmune Diseases

Treatments

Biological: GT719 Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07021209

GRIT-CD-CHN-719-002

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.