Actively Recruiting
GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
Led by Grit Biotechnology · Updated on 2026-04-16
30
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
G
Grit Biotechnology
Lead Sponsor
A
Affiliated Hospital of Nantong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.
CONDITIONS
Official Title
GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enrolled in the study, signed informed consent, and able to follow the study protocol
- Aged 18 to 65 years, any gender
- Diagnosed with systemic lupus erythematosus meeting 2019 EULAR/ACR criteria with specific disease activity scores
- Diagnosed with idiopathic inflammatory myopathy meeting 2017 EULAR/ACR criteria, positive for myositis antibodies, and experiencing refractory or progressive disease
- Diagnosed with systemic sclerosis meeting 2013 ACR criteria, positive for related antibodies, and with refractory or progressive disease
You will not qualify if you...
- Used complement inhibition therapy (e.g., Ecuzumab) within 3 weeks before lymphodepleting chemotherapy
- Received live attenuated vaccine within 4 weeks before lymphodepleting chemotherapy
- Had major surgery within 8 weeks before screening or plan to undergo surgery during the study
- History of organ transplantation
- Previously treated with CAR-T therapy targeting any target other than GT719
- Conditions that interfere with participation or trial results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Actively Recruiting
Research Team
Z
Zhifeng Gu
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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