Clinical Trial

A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractory Autoimmune Diseases

Recruiting Early Phase 1
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Summary
This is a single-arm, open-label, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy, and cellular metabolism kinetics of GT801 in the treatment of moderate-to-severe refractory autoimmune diseases. Interim analysis will be conducted when 5 patients complete primary endpoint measurement.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-31.
Trial Details
NCT Number NCT07333118
Lead Sponsor Grit Biotechnology
Collaborators: Shanghai Changzheng Hospital
Conditions Moderate to Severe Refractory Autoimmune Disease
Enrollment 22 participants
Start Date 2025-11-07
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-27