New injection aims to tame stubborn autoimmune diseases
NCT ID NCT07132112
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests an injection called GT719 in 30 people with moderate to severe autoimmune diseases like lupus that haven't responded to standard treatments. The main goal is to check safety and find the right dose, while also looking at whether it helps control disease activity. Participants will be monitored closely for side effects and any improvement in their condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol. * 2\. Aged 18 to 65 years (inclusive), regardless of gender. Specific inclusion criteria: * 3\. Participants with systemic lupus erythematosus (SLE) 1. Meets the classification criteria for SLE in the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR); 2. Disease activity score SLEDAI-2000 ≥ 6, with at least one British Islet Lupus Assessment Group Index (BILAG-2004) Grade A (severe manifestations) or two Grade B (moderate manifestations) organ scores, or both; Or the disease activity score SLEDAI-2000 ≥ 8; * 4\. Participants with idiopathic inflammatory myopathy (IIM) 1. Complies with the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS, and NM) 2. Myositis antibody positive; 3. . Meets the definition of recurrence, refractory or progressive; * 5\. Participants with systemic sclerosis 1. . Meet the 2013 American College of Rheumatology (ACR) SSc criteria; 2. . SSc related antibodies are positive; 3. . Meets the definition of refractory or progressive recurrence Exclusion Criteria: * 1\. Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used; * 2\. Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy; * 3\. Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period; * 4\. Medical history of organ transplantation; * 5\. Previously received CAR-T product therapy targeting any target (excluding GT719 therapy); * 6\. According to the investigator's judgment, the situations that hinder participants from participating in the entire trial, confound the trial results, or participate in the trial that are not in the best interests of the participants.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Nantong University
RECRUITINGNantong, Jiangsu, China
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