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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

NCT07614191 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-05-29

No results posted yet for this study

Summary

This study is an open-label, single-arm, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy and cellular pharmacokinetics of GT801 injection in patients with moderate to severe refractory autoimmune diseases.

Conditions

  • Moderate to Severe Refractory Autoimmune Diseases

Interventions

BIOLOGICAL

GT801 Injection

GT801 Injection

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Vivacta Biotechnology (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2031-12-30
Completion
2031-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614191 on ClinicalTrials.gov