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

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Secondary endpoints revised (11)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07333118
Lead Sponsor Grit Biotechnology
Collaborators: Shanghai Changzheng Hospital
Conditions
(from sponsor)		 Moderate to Severe Refractory Autoimmune Disease
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov