Actively Recruiting
A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Rheumatoid Arthritis
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-04-15
54
Participants Needed
1
Research Sites
141 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 rheumatoid arthritis.
CONDITIONS
Official 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...
- Able to understand and voluntarily sign informed consent
- Any gender
- Aged 18 to 75 years
- Life expectancy longer 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
- If previously treated with antirheumatic drugs other than methotrexate, leflunomide stopped at least 8 weeks prior or cholestyramine used for 14 days
- Erythrocyte sedimentation rate (ESR) over 28 mm/hr or C-reactive protein (CRP) over 10 mg/L
- Positive rheumatoid factor or anti-cyclic citrullinated peptide antibodies
- Presence of CD19+ B cells in peripheral blood
- Rheumatoid arthritis diagnosis for more than 6 months
- Organ function meets requirements before first administration
- Fertile participants must use effective contraception from 7 days before first dose until 24 weeks after treatment ends and avoid donating eggs/sperm for 1 year
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Able and willing to comply with study visits, treatment, lab 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 GNC-038 treatment
- Use of anti-TNF drugs within 8 weeks before dosing
- Use of JAK inhibitors within 2 weeks before dosing
- Use of antimalarial drugs, sulfasalazine, penicillamine, or similar within 4 weeks before dosing
- Use of phytochemicals within 4 weeks before dosing
- Use of other biological agents or non-B cell depleting investigational drugs exceeding 5 half-lives before dosing
- Intra-articular injection within 4 weeks before study entry
- Participation in other investigational drug trials within 28 days or 5 half-lives
- ACR functional class IV or bedridden/wheelchair-bound
- History of major organ, hematopoietic stem cell, or bone marrow transplantation
- Active hepatitis B, hepatitis C, HIV, or syphilis infection
- Cardiovascular disease history within 6 months before screening
- Poorly controlled high blood pressure
- Prolonged QT interval at rest
- Recent significant bleeding or need for continuous anticoagulant therapy
- Allergy to humanized antibodies or GNC-038 components
- Pregnant or breastfeeding women
- Recent suicidal thoughts considered high risk
- Malignant tumor diagnosis within 5 years
- Poor compliance or unwillingness to follow study
- History of splenectomy
- Alcohol or drug abuse in past 12 months
- Active infection needing antibiotics within 2 weeks before or during screening
- History of severe or widespread viral infection
- Possible 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
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