Actively Recruiting
A Randomized Controlled Phase I Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Rheumatoid Arthritis
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-04-15
54
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic properties of GNC-038, a tetra-specific antibody injection, in patients with rheumatoid arthritis. This phase I clinical study includes two parts: a phase Ia single-arm study and a phase Ib randomized controlled study with a placebo group. The study aims to understand the treatment's effects in patients who have moderate to severe rheumatoid arthritis and meet specific diagnostic criteria. Participants receive GNC-038 by intravenous infusion once a week for two doses in the first cycle. Those who show clinical benefit may receive additional treatment cycles until disease progression, intolerable toxicity, or other reasons require stopping. In phase Ib, a control group receives a placebo based on doses determined in phase Ia. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. During the study, participants will undergo regular safety and efficacy assessments, including monitoring adverse events and measuring drug levels in the blood. Researchers will evaluate rheumatoid arthritis activity using criteria such as ACR20 remission and quality of life changes over up to 24 months. Participants must follow scheduled visits, treatment plans, laboratory tests, and other study procedures throughout the study period.
CONDITIONS
Brief Title
A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent
- Any gender
- Age 18 to 75 years
- Life expectancy greater than 6 months
- Diagnosed with rheumatoid arthritis by 1987 or 2010 ACR/EULAR criteria
- Moderate to severe active rheumatoid arthritis at screening
- Stable standard-of-care treatment for at least 30 days before first dose
- Discontinued leflunomide at least 8 weeks before study or used cholestyramine for 14 days if previously treated with antirheumatic drugs other than methotrexate
- Elevated erythrocyte sedimentation rate (ESR) > 28 mm/hr or C-reactive protein (CRP) > 10 mg/L
- Positive rheumatoid factor and/or anti-cyclic citrullinated peptide antibodies
- Presence of CD19+ B cells in peripheral blood
- Rheumatoid arthritis diagnosis for more than 6 months
- Organ function levels meeting requirements before first administration
- Fertile participants must use highly effective contraception from 7 days before first dose until 24 weeks after treatment ends and agree not to donate reproductive material for 1 year after last treatment
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Able and willing to comply with study visits, treatment plans, laboratory tests, and procedures
You will not qualify if you...
- Diagnosis of another autoimmune rheumatic disease
- B cell-targeted therapy within 6 months before GNC-038 treatment
- CAR-T therapy within 6 months before treatment
- Use of anti-TNF drugs within 8 weeks before administration
- Use of JAK inhibitors within 2 weeks before dosing
- Use of antimalarial drugs, sulfasalazine, penicillamine, or phytochemicals within 4 weeks before administration
- Use of other biological agents or non-B cell depleting investigational drugs within 5 half-lives before administration
- Intra-articular injection within 4 weeks before study entry
- Use of any investigational drug within 28 days or within 5 half-lives before dosing
- ACR functional class IV or bedridden/wheelchair-bound
- History of major organ or stem cell transplantation
- Active hepatitis B, hepatitis C, HIV, or syphilis infection
- History of cardiovascular disease within 6 months before screening
- Poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Prolonged QT interval at rest
- Recent significant bleeding or need for long-term anticoagulant therapy
- Allergy to recombinant humanized antibodies or GNC-038 excipients
- Pregnant or breastfeeding women
- History or evidence of suicidal thoughts within 6 months before consent
- Malignant tumor diagnosis within 5 years before consent
- Poor compliance or unwillingness to follow protocol
- History of splenectomy
- History of alcohol or drug abuse within 12 months before screening
- Active infection requiring systemic antibiotic treatment within 2 weeks before or during screening
- History of severe or disseminated viral infection
- Active Mycobacterium tuberculosis infection may be present
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive GNC-038 or placebo by intravenous infusion once a week, twice in total. Participants with clinical benefit may receive additional treatment cycles until disease progression, intolerable toxicity, or other reasons lead to treatment termination.
Weekly visits for at least 2 weeks, with additional visits if receiving further treatment cycles
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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