Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits

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Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 30
Trial details
Phase: Early Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Grit BiotechnologyUpdated: Apr 23, 2026Locations: 1
Eligibility criteria

1. The participant or their legal representative voluntarily signs a written inf... [+22]

Drug-induced or secondary AAV/AAGN. [+38]