Actively Recruiting
GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases
Led by Grit Biotechnology · Updated on 2025-09-22
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective single-arm open-label clinical trial, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune diseases. A total of 10 subjects will be enrolled in this study.
CONDITIONS
Official Title
GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enrolled and able to comply with study protocol
- Aged 18 to 65 years, any gender
- Adequate bone marrow, liver, kidney, coagulation, and heart function as specified
- Women of childbearing age must have a negative pregnancy test and agree to contraception and breastfeeding restrictions
- Specific diagnosis criteria for systemic lupus erythematosus, inflammatory myopathy, or diffuse systemic sclerosis with refractory or progressive disease despite conventional treatment
You will not qualify if you...
- Drug-induced SLE or lupus crisis requiring contraindicated drugs
- Inclusion body myositis or non-inflammatory myopathies
- Severe uncontrolled extramuscular disease damage in inflammatory myopathy
- Moderate to severe pulmonary arterial hypertension or rapidly progressive gastrointestinal involvement in systemic sclerosis
- History of severe allergies or hypersensitivity to study drugs
- Severe heart diseases including recent myocardial infarction or severe arrhythmias
- Active or recent malignant tumors except certain early-stage cancers
- Significant bleeding disorders or recent thrombotic events
- Serious infections or central nervous system disorders
- Positive tests for HIV, hepatitis B or C, syphilis, CMV, or EBV
- Active or untreated tuberculosis
- Recent use of other clinical trial drugs or certain immunotherapies
- Recent major surgery or planned surgery during study
- History of organ transplantation or prior CAR-T therapies excluding GT719
- Other conditions or factors judged by investigators to interfere with participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, China
Actively Recruiting
Research Team
H
Huji Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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