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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

GT719 Injection
Biological/Vaccine
GT719 Injection

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: GT719 Injection treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence and severity of adversed events

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

Time frame

24 months

Secondary outcomes

Pharmacokinetics of GT719 cells

Survival time of GT719 cells after infusion of GT719 Injection

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grit Biotechnology

Lead sponsor

Tongji Hospital

Collaborator

Source ClinicalTrials.gov

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