GT719 injection for people with moderate to severe refractory autoimmune disease.

A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Disease

This trial will test whether GT719 injections are safe and can help adults aged 18-65 whose moderate to severe autoimmune disease has not responded to other treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Drugs / interventions: Ecuzumab, CAR-T, chemotherapy
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT07132112 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, open-label early phase 1 trial with dose-escalation and expansion cohorts enrolling 30 participants. Adult patients with moderate to severe refractory autoimmune disease — including specified systemic lupus erythematosus and antibody-positive idiopathic inflammatory myopathy cases — will receive GT719 injections and be monitored for safety, clinical response, and cellular pharmacokinetics. The trial will collect clinical disease activity measures and laboratory data over defined follow-up visits to characterize tolerability and early signs of efficacy. Results will inform dosing and feasibility for later-stage studies.

Who should consider this trial

Good fit: Ideal candidates are adults 18-65 with moderate to severe refractory autoimmune disease, such as SLE meeting 2019 EULAR/ACR criteria with SLEDAI-2000 ≥6 (or ≥8) or antibody-positive idiopathic inflammatory myopathy that is recurrent, refractory, or progressive and who have failed standard therapies.

Not a fit: Patients with mild disease, autoimmune conditions not specified in the trial criteria, children, adults over 65, or those with contraindications to the investigational injection are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, GT719 could reduce disease activity and provide a new treatment option for adults with refractory autoimmune disease.

How similar studies have performed: Some targeted biologic and cell-directed therapies have shown benefit in refractory autoimmune diseases, but GT719 appears to be a novel agent with very limited prior human data.

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.

Where this trial is running

Nantong, Jiangsu

• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhifeng Gu

Conditions Auto Immune Disease