Actively Recruiting
Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-09-17
25
Participants Needed
2
Research Sites
123 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
I
ITabMed Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody (A-319) in active/refractory systemic lupus erythematosus (SLE).
CONDITIONS
Official Title
Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-60 years old, regardless of gender
- Diagnosed with systemic lupus erythematosus (SLE) according to American College of Rheumatology (ACR) 1997 criteria at least 24 weeks before consent
- Active or refractory systemic lupus erythematosus
- Positive for at least one autoantibody: antinuclear antibodies (ANA) at titer 1:80, anti-dsDNA, or anti-Smith (anti-Sm)
- Receiving standardized and stable treatment for at least 30 days before first study drug administration
- Female participants must test negative for pregnancy and agree to use effective contraception during the trial
- Ability to understand the study and voluntarily sign informed consent
- Able to communicate well with researchers and complete all study visits as required
You will not qualify if you...
- Severe kidney disease
- Central nervous system diseases caused by SLE or other causes within 8 weeks before first study drug administration
- Abnormal main organ function at screening
- Medical history posing safety risks or affecting study drug safety or effectiveness analysis
- Active mycobacterium tuberculosis infection
- Active hepatitis or positive hepatitis B or C virus markers with detectable viral DNA or RNA
- History of HIV infection or positive HIV antibodies at screening
- Positive syphilis spirochete antibody at screening (except false positive from SLE)
- Chronic active infection or acute infection requiring systemic treatment within 2 weeks before screening, or superficial skin infection needing treatment within 1 week before screening
- Major surgery or unhealed wounds, ulcers, or fractures within 4 weeks before first study drug administration, or planned major surgery during study
- Diagnosis of malignant tumors within 5 years before screening
- History of major organ or hematopoietic stem cell/bone marrow transplantation
- Vaccinated with or planning live or live attenuated vaccines within 4 weeks before first study drug administration
- Participation in any clinical trial within 4 weeks before first study drug administration or within 5 half-lives of the study drug from another trial
- Use of targeted drugs like rituximab or JAK inhibitors within specified time before first study drug administration
- Use of intravenous immunoglobulin, high-dose prednisone (≥100mg/day) or equivalent glucocorticoids within 4 weeks before first study drug administration, or plasma replacement
- Use of IL-2, thalidomide, rethidone, or traditional Chinese medicine within 4 weeks before first study drug administration
- Known allergies to monoclonal antibody drugs or A-319 excipients
- Depression or suicidal thoughts
- Pregnant or breastfeeding women, or those planning pregnancy or breastfeeding during the study; or men with partners planning pregnancy during the study
- Any condition that researchers believe will hinder participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
2
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
Research Team
Q
Qiubai Li, Professor
CONTACT
D
Di Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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