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 18 years old or older (any gender)
• You have been diagnosed with Systemic Lupus Erythematosus (SLE or lupus) according to recognised medical guidelines
• You have already tried several standard lupus treatments — including hydroxychloroquine, steroids at a certain dose, up to two immunosuppressant medications, and at least one approved biological treatment — for a total of at least 3 months, but your lupus is still active or you cannot tolerate these treatments
• Your lupus disease activity score (SLEDAI-2K) is 7 or higher, meaning your lupus is considered moderately to highly active
• Your blood tests show positive results for certain lupus-related antibodies (ANA and/or anti-dsDNA)
• Your heart, kidneys, liver, and lungs are working well enough to meet specific medical standards (confirm with trial site)
• You do not have serious mental health disorders
• Your veins are suitable for blood collection or a filtering procedure used to collect cells
• You agree to use reliable contraception (not rhythm/calendar methods) from signing the consent form until one year after receiving the study treatment, and you agree not to donate eggs or sperm during that time
• If you are a woman who could become pregnant, you have a negative blood pregnancy test before joining

Who may not be able to join:

• You currently have severe, active lupus affecting your brain or nervous system that needs treatment right now
• You have had serious kidney inflammation recently, including needing dialysis or kidney replacement therapy within the past 3 months, or your kidneys are getting significantly worse (stable lupus kidney disease that is controlled may still be considered — confirm with trial site)
• You have another lupus-related crisis that is not under control at the time of screening
• You have previously received CAR-T therapy or any other gene-modified cell therapy
• You have another autoimmune disease that requires treatment affecting your whole body
• You have active hepatitis B, hepatitis C, HIV, or syphilis infections based on blood tests
• You have significant heart problems, including severe heart failure (NYHA stage III or IV), a heart attack or heart surgery within the past 6 months, a history of serious heart rhythm problems requiring treatment, unexplained fainting, or severe non-ischemic cardiomyopathy
• You have an infection that is not under control in the week before joining
• You have previously had an organ transplant or a stem cell transplant
• You had a stroke or seizure within the past 6 months
• You had a serious blood clot in a deep vein or artery within the past 6 months
• You have a history of cancer, with some exceptions for certain fully treated cancers (confirm with trial site)
• You received a live or weakened live vaccine within 4 weeks before screening
• You have participated in another clinical trial within one month before joining (or within five half-lives of the last study drug — whichever is shorter)
• You are currently pregnant or breastfeeding, or you or your partner plan to have a child within one year after receiving the study treatment
• The trial doctors decide there is another reason you should not participate

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