Early 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 (or your guardian) must be willing and able to sign a consent form approved by an ethics committee before any screening begins
• You must be 18 years of age or older (any gender)
• You must have been formally diagnosed with systemic lupus erythematosus (SLE, or lupus) according to recognised 2012 international guidelines
• You must have had lupus for at least 6 months before screening, and your disease must still have been active for at least 2 months while on a stable standard lupus treatment plan
• Your standard lupus treatment must have included steroid medicines (such as prednisone) and one or more immune-suppressing drugs for at least 6 months, with the steroid dose kept stable for more than 2 weeks before screening (confirm with trial site for exact dose requirements)
• Certain lupus-related antibodies (antinuclear antibodies, anti-dsDNA, or anti-Smith) must show up as positive in your blood tests during screening
• Your lupus disease activity must reach a certain level, measured by a specific scoring system called SELENA-SLEDAI (confirm with trial site for exact score requirements)
• Women who could become pregnant, and all male participants, must agree to use effective contraception for at least 12 months after receiving the trial treatment, and until follow-up tests confirm the treatment cells are no longer detectable in the body
• A specific protein called CD19 must be detectable on your cells, confirmed by a laboratory test
• Your blood counts must meet minimum levels — including white blood cells, platelets, and haemoglobin — tested shortly before a cell collection procedure
• Your liver and kidney function, blood clotting, and certain other blood chemistry results must be within acceptable ranges (confirm with trial site for specific values)
• You must have no more than mild breathing difficulties, and your blood oxygen level must be above 91% while breathing normal indoor air
• Your heart must be functioning adequately, with a pumping efficiency (LVEF) of at least 45%, confirmed by a heart scan

Who may not be able to join:

• People with severe lupus kidney disease, defined by very high protein levels in the urine, significantly reduced kidney function, the need for dialysis, or recent use of very high-dose steroids for kidney-related lupus
• People who have recently experienced a serious lupus flare affecting other organs, such as the brain, blood, heart, lungs, liver, or blood vessels (confirm with trial site for specific conditions)
• People who have significant brain or nervous system conditions unrelated to lupus, such as stroke, epilepsy, dementia, Parkinson's disease, severe brain injury, or psychosis
• People who have another autoimmune disease that requires ongoing systemic (whole-body) treatment
• People who have had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell or bone marrow transplant in the past
• People found to have very low levels of a specific immune protein called IgA in their blood during screening
• People whose doctor or the trial investigator believes should not participate for any other medical reason

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