RecruitingEarly Phase 1NCT07333118

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


Sponsor

Grit Biotechnology

Enrollment

22 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called GT801 for people with severe autoimmune diseases like lupus (SLE), myositis, or systemic sclerosis that have not responded to standard treatments. CAR-T therapy uses a patient's own immune cells, re-engineered in a lab to target the cells causing the autoimmune attack. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with systemic lupus erythematosus (SLE), myositis, or systemic sclerosis - Your disease is active and has not responded to at least 6 months of conventional treatment (steroids plus other immunosuppressants) - Your organ function and blood counts meet study requirements **You may NOT be eligible if...** - You have a serious active infection (including HIV or active hepatitis B/C) - You have significant heart, lung, liver, or kidney disease - You are pregnant or breastfeeding - You have received certain prior therapies (like other CAR-T treatments) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGT801 Injection

GT801 Injection


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT07333118