Actively Recruiting
A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-06-24
54
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.
CONDITIONS
Official Title
A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- No gender restriction
- Age between 18 and 75 years
- Life expectancy greater than 6 months
- Diagnosed with SLE according to 2019 EULAR/ACR criteria
- Moderate to severe SLE with SLEDAI-2K score greater than 7 at screening
- Stable standard-of-care treatment for at least 30 days before first dose
- Positive ANA (≥ 1:80) or anti-dsDNA antibody above normal range at screening
- Presence of CD19+ B cells in peripheral blood
- Organ function meets study requirements before first administration
- Use of effective contraception for childbearing potential from 7 days before first dose until 24 weeks after treatment ends
- Negative pregnancy test for females of childbearing potential within 7 days before first dose
- Willing and able to comply with all study visits, treatments, and tests
You will not qualify if you...
- Severe lupus nephritis within 8 weeks before screening
- Uncontrolled lupus crisis within 8 weeks before screening
- Active encephalopathy or psychosis within 6 months before screening
- Primary diagnosis of other autoimmune or inflammatory diseases
- B cell-depleting therapy within 6 months before treatment
- CAR-T therapy within 6 months before treatment
- Cytokine-targeting biologics within 12 weeks before dosing
- Anti-tumor necrosis factor drugs within 8 weeks before dosing
- Any JAK inhibitor within 2 weeks before dosing
- Use of investigational drugs within 28 days or 5 half-lives before dosing
- History of major organ or bone marrow transplantation
- Active hepatitis B, hepatitis C, HIV, or syphilis infection
- Cardiovascular disease history within 6 months before screening
- Poorly controlled hypertension (≥160/100 mmHg)
- Prolonged QT interval at rest
- History of significant bleeding or need for long-term anticoagulants
- Allergy to humanized antibodies or GNC-038 components
- Pregnant or breastfeeding women
- History of suicidal thoughts within 6 months
- Malignant tumor diagnosis within 5 years
- Poor compliance or unwillingness to follow protocol
- History of splenectomy
- Alcohol or drug abuse history within 12 months
- Active infection requiring antibiotics within 2 weeks
- History of severe or widespread viral infections
- Active tuberculosis infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here