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New treatment option for Auto Immune Disease
Official title GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
ClinicalTrials.gov ID: NCT07132112
What this study is testing
What is GT719 Injection?
GT719 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for auto immune disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
- 3\. Participants with systemic lupus erythematosus (SLE)
- Meets the classification criteria for SLE in the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR);
- Disease activity score SLEDAI-2000 ≥ 6, with at least one British Islet Lupus Assessment Group Index (BILAG-2004) Grade A (severe manifestations) or...
You likely can't join if
- 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...
See the full eligibility 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
- 3\. Participants with systemic lupus erythematosus (SLE)
- Meets the classification criteria for SLE in the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR);
- 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...
- 4\. Participants with idiopathic inflammatory myopathy （IIM）
- Complies with the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS, and NM)
- Myositis antibody positive;
- . Meets the definition of recurrence, refractory or progressive;
- 5\. Participants with systemic sclerosis
- . Meet the 2013 American College of Rheumatology (ACR) SSc criteria;
- . SSc related antibodies are positive;
- . Meets the definition of refractory or progressive recurrence
- 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 study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.