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New treatment option for Systemic Lupus Erythematosus
Official title Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06400537
What this study is testing
What is A-319?
A-319 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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...
- Receive the standardized and stable treatment for at least 30 days before the first administration of the study drug;
You likely can't join if
- Severe kidney disease;
- Participants who have central nervous system diseases caused by SLE or non-SLE disease within 8 weeks before the first administration of the study...
- Abnormities of main organ function at screening;
- Medical history that the researchers believe will pose risk to the safety of the participants, or will affect the safety or how well it works...
- 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...
See the full eligibility criteria
- 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.
- Severe kidney disease;
- 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;
- Abnormities of main organ function at screening;
- Medical history that the researchers believe will pose risk to the safety of the participants, or will affect the safety or how well it works analysis of the study drug;
- 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...
- History of human immunodeficiency virus infection, or positive antibodies at screening;
- 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;
- Participants diagonosed with malignant tumors within 5 years before screening;
- History of important organ transplantation or hematopoietic stem cells/or bone marrow transplantation;
- 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;
- Known allergies to monoclonal antibody drugs, or allergies to A-319 excipients;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Taiyuan, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Taiyuan, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.