NCT07389499

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Grit Biotechnology · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase. In the dose-escalation phase, approximately 9-18 adult participants with immune-mediated kidney diseases are planned to be enrolled and treated with GT719 universal cell injection. The objectives of this phase are to evaluate the safety and tolerability of the product, determine the recommended dose (RD) for subsequent studies, conduct a preliminary assessment of its clinical efficacy, and investigate the pharmacokinetic and pharmacodynamic characteristics. Upon completion of the dose-escalation phase, after evaluation by investigators and collaborators, an appropriate dose will be selected for the dose-expansion phase. An additional 12 participants will be enrolled to fully assess the safety and efficacy of the product.

Conditions

• IgA Nephropathy (IgAN)
• Membranous Nephropathy
• ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN)
• Refractory Podocytopathy
• Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits

Interventions

Type	Name	Description
BIOLOGICAL	CD19-targeted iNKT Cell Injection	Composed of CD19-targeted iNKT cells

Timeline

• Start date: 2026-01-31
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: China