Actively Recruiting
A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
Led by Grit Biotechnology · Updated on 2026-04-16
30
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety, effectiveness, and how GT719 Injection behaves in the body for patients with moderate to severe autoimmune diseases that have not responded to other treatments. This early-phase, open-label clinical trial will enroll 30 participants to better understand this new biological treatment. The study focuses on patients with systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy. Participants will receive GT719 Injection as the treatment during the study. The trial includes a dose escalation and expansion phase, where the amount of GT719 given may be adjusted. This single-arm study means all participants receive the GT719 Injection without a comparison group. Evaluations for effectiveness will occur at 14 days and then at 1, 2, 3, and 6 months after receiving the infusion. During the study, participants will be monitored closely for any side effects or dose-related toxicities over 28 days and for treatment-related adverse events over a 2-year period. The researchers will assess disease activity using specific clinical scores related to lupus, systemic sclerosis, and inflammatory myopathy at scheduled intervals. The total duration of participation includes follow-up visits over several months to evaluate safety and treatment impact.
CONDITIONS
Brief Title
GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enrolled, signed informed consent, and willing to follow the study protocol
- Aged 18 to 65 years (inclusive), any gender
- Diagnosed with systemic lupus erythematosus (SLE) meeting 2019 EULAR/ACR criteria with specific disease activity scores
- Diagnosed with idiopathic inflammatory myopathy (IIM) meeting 2017 EULAR/ACR criteria with positive myositis antibodies and refractory or progressive disease
- Diagnosed with systemic sclerosis meeting 2013 ACR criteria with positive SSc antibodies and refractory or progressive disease
You will not qualify if you...
- Received lymphodepleting chemotherapy or complement inhibition therapy within 3 weeks prior
- Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy
- Underwent major surgery within 8 weeks prior to screening or plans surgery during the study
- History of organ transplantation
- Previously received CAR-T therapy targeting any treatment other than GT719
- Any condition judged by the investigator to interfere with trial participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive the GT719 Injection to treat moderate to severe refractory autoimmune disease.
1 baseline visit and multiple follow-up visits up to 6 months post-infusion
Duration - 2 years
Participants are monitored for treatment-emergent adverse events and efficacy outcomes over 2 years.
Visits at 14 days, 1, 2, 3, 6 months, and periodic assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Actively Recruiting
Research Team
Z
Zhifeng Gu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here