NCT07132112 GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
| NCT ID | NCT07132112 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Grit Biotechnology |
| Condition | Auto Immune Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-10-28 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07132112 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Auto Immune Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07132112 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07132112 currently recruiting?
Yes, NCT07132112 is actively recruiting participants. Contact the research team at guzhifeng@126.com for enrollment information.
Where is the NCT07132112 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT07132112 clinical trial?
NCT07132112 is sponsored by Grit Biotechnology. The trial plans to enroll 30 participants.