GR1803 for systemic lupus erythematosus (SLE)
Official title: A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus
Run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · NCT07348055 · Data updated 2026-11-12
This trial will test GR1803 injections in people with active systemic lupus (SLE) to see if the drug is safe and helps control lupus symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07348055 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed diagnosis of SLE, active disease (SLEDAI-2K ≥ 6), and stable background treatment who can provide informed consent and comply with visits are the intended participants.
✕Probably not a fit
Patients with mild or well-controlled lupus below the SLEDAI threshold, active infections, unstable comorbidities, or recent cancer are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an early-phase (Phase 1/2) interventional study of GR1803, a BCMA/CD3 bispecific antibody given by injection, in patients with active systemic lupus erythematosus. The trial is designed to identify safe dose levels and then expand into cohorts to look for initial signs of benefit. Eligible participants must have confirmed SLE with SLEDAI-2K ≥ 6 and be on stable background therapy (glucocorticoids, antimalarials, or immunosuppressants). Key exclusions include active infection, unstable medical conditions, or a history of malignancy within five years, and the study is being conducted at Union Hospital, Tongji Medical College in Wuhan, Hubei.
Why it matters
Potential benefit: If successful, GR1803 could offer a new targeted immune therapy that reduces lupus activity for patients who remain symptomatic on standard treatments.
How similar studies have gone: Using BCMA/CD3 bispecific antibodies is mainly an emerging approach with limited prior data in autoimmune diseases, so this application to SLE is relatively novel and early-stage.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * comfirmed diagnosis of systemic lupus erythematosus * SLEDAI-2K≥6分 * written informed consent and ability to comply with protocol requirements * have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months Exclusion Criteria: * with unstable acute and chronic diseases * active infection * history of malignant tumor within 5 years
Where it's running
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Nian
- Email: nianhanli@genrixbio.com
- Phone: 021-50805989-08324
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.