Tests A-319 in adults with active or hard-to-treat lupus
Tests the drug A-319 in adults with active or hard-to-treat lupus.
Plain-language title generated from the registry record
Registry title: Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus
Key facts
- Where
- Taiyuan and Wuhan, ChinaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06400537, who can take part
Where in China
- Shanxi Bethune HospitalTaiyuan, ChinaTaking people
- Wuhan Union HospitalWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT06400537
- Record updated
- 17 September 2025
- Original description
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).Read full original descriptionShow less
Clinical Study of Recombinant CD19xCD3 Double Antibody (A-319) in the Treatment of Active/Refractory Systemic Lupus Erythematosus
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).
Inclusion: Age 18-60 years old, regardless of gender; Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form; Active/refractory systemic lupus erythematosus; Positive test results for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) immunofluorescence assay at a titer of ≥1:80; anti-dsDNA; or anti-Smith (anti-Sm); Receive the standardized and stable treatment for at least 30 days before the first administration of the study drug; Female participants tested negative for pregnancy, and participants agreed to use effective contraception throughout the trial; Have the ability to understand the nature of the research and voluntarily sign an informed consent form; Participants can communicate well with the researchers and complete all visits according to the requirements of the plan.
Exclusion: Participants who have central nervous system diseases caused by SLE or non-SLE disease within 8 weeks before the first administration of the study drug; Medical history that the researchers believe will pose risk to the safety of the participants, or will affect the safety or effectiveness analysis of the study drug; Positive syphilis spirochete antibody at screening (except false positive caused by SLE); Participants with chronic active infection or acute infection need systemic anti-infection treatment within 2 weeks before screening, or have superficial skin infection requiring treatment within 1 week before screening; Have undergone major surgery or unhealed wounds, ulcers or fractures within 4 weeks before the first administration of the study drug, or plan to perform major surgery during the study period; Have been vaccinated or plan to receive live vaccine or live attenuated vaccine during the research period within 4 weeks before the first administration of the study drug; Participated in any clinical trial within 4 weeks before the first administration of the study drug or within 5 half-lives of the study drug of the clinical trial; Received targeted drugs (rituximab, JAK inhibitors, etc.) at a specific time period before the first administration of the study drug; Received intravenous immunoglobulin, prednisone ≥100mg/d or equivalent glucocorticoid therapy within 4 weeks before the first administration of the study drug, or plasma replacement; Received IL-2, thalidomide, rethidone and traditional Chinese medicine within 4 weeks before the first administration of the study drug; Severe kidney disease; Active mycobacterium tuberculosis infection; Active hepatitis, or hepatitis B virus surface antigen positive, or hepatitis B virus core antibody positive and hepatitis B virus deoxyribonucleic acid positive, ,or hepatitis C virus (HCV) antibody positive with detectable HCV ribonucleic acid (RNA); History of human immunodeficiency virus infection, or positive antibodies at screening; Participants diagonosed with malignant tumors within 5 years before screening; History of important organ transplantation or hematopoietic stem cells/or bone marrow transplantation; Known allergies to monoclonal antibody drugs, or allergies to A-319 excipients; Abnormities of main organ function at screening; Participants with depression or suicidal thoughts; Women who are pregnant or breastfeeding, or women who plan to be pregnant or breastfeeding during the study period; or men whose sexual partners plan to become pregnant during the study period; Any reason that the researchers believe will hinder the subject's participation in the study.