Phase 1 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 60 years old (any gender)
• You were diagnosed with lupus (SLE) at least 24 weeks before signing the consent form, using recognized medical guidelines
• Your lupus is currently active or has not responded well to previous treatments
• At least one specific lupus-related antibody was found in your blood during screening (confirm with trial site)
• You have been on a stable, standard lupus treatment for at least 30 days before the study drug is first given
• If you are a woman, you tested negative for pregnancy and agreed to use effective birth control throughout the trial
• You are able to understand what the study involves and are willing to sign a consent form
• You are able to communicate with the research team and attend all required visits

Who may not be able to join:

• You have severe kidney disease
• You have had a nervous system condition caused by lupus or another illness within 8 weeks before the study drug starts
• Your major organs (such as liver or heart) are not functioning normally at the time of screening
• You have a medical history that the research team believes could put you at risk or affect the study results
• You currently have an active tuberculosis infection
• You have active hepatitis, or certain hepatitis B or C virus markers were found in your blood
• You have a history of HIV infection, or HIV antibodies were found at screening
• You tested positive for syphilis at screening (unless the result is a known false positive caused by lupus)
• You have had a serious ongoing infection or a recent acute infection needing treatment within 2 weeks before screening, or a skin infection needing treatment within 1 week before screening
• You had major surgery, or have an unhealed wound, ulcer, or fracture within 4 weeks before the study drug starts, or you plan to have major surgery during the study
• You were diagnosed with cancer within the past 5 years before screening
• You have had a major organ transplant, bone marrow transplant, or stem cell transplant
• You received a live vaccine within 4 weeks before the study drug starts, or plan to receive one during the study
• You took part in another clinical trial within 4 weeks before the study drug starts (or within a specific timeframe related to that trial's drug)
• You received certain targeted medicines (such as rituximab or JAK inhibitors) within a specific period before the study drug starts (confirm exact timeframe with trial site)
• You received high-dose steroid treatment (prednisone 100mg/day or equivalent), intravenous immunoglobulin, or plasma exchange within 4 weeks before the study drug starts
• You received certain other medicines, including IL-2, thalidomide, or specific traditional Chinese medicines, within 4 weeks before the study drug starts
• You have a known allergy to monoclonal antibody medicines or to ingredients in the study drug (A-319)
• You have depression or thoughts of suicide
• You are pregnant or breastfeeding, plan to become pregnant or breastfeed during the study, or your male partner's partner plans to become pregnant during the study
• The research team has any other reason to believe you should not participate

Important: Always verify eligibility with the trial site directly before applying.