Phase 1 Lupus Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 to 65 years old, of any gender.
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) according to the 2019 international diagnostic guidelines.
• People in the lupus nephritis (kidney-related lupus) subgroup must have a specific type of active kidney inflammation (type III or IV, with or without type V) confirmed by a kidney biopsy, meeting certain activity and damage level thresholds, and showing significant protein in the urine.
• People who have tested positive for at least one of the following at the screening stage: antinuclear antibody (ANA), anti-dsDNA antibody, or anti-Smith antibody (these are specific blood markers associated with lupus).
• People whose lupus disease activity score (called SLEDAI-2000) is 8 or higher at screening, indicating active disease.
• People who have been taking a stable combination of steroid medications and at least one other immune-suppressing or biologic medication for at least 3 months before screening, with the dose unchanged for more than 2 weeks, but whose disease remains active (treatment with only one type of medication on its own would not meet this criterion).
• People whose blood cell counts, liver function, kidney function, lung function, and heart function fall within specific acceptable ranges at screening (confirm with trial site for exact values).
• People who are not on blood-thinning medication must have blood clotting levels within an acceptable range at screening.
• People who have recently received certain blood-support treatments (such as growth factor injections or blood transfusions) must have waited a specified period before their screening assessments (confirm with trial site for exact timeframes).
• Women who could potentially become pregnant must have a negative pregnancy blood test at screening.
• People of childbearing potential (both female and male) must agree to use highly effective contraception throughout the study and for one year after the last treatment, and must agree not to donate eggs or sperm for assisted reproduction during that same period.
• People who are willing to take part in the study and sign a written consent form.

Who may not be able to join:

• People who are currently on dialysis (kidney filtering treatment) or are expected to need dialysis during the study.
• People who have previously had, or are planning to have, a solid organ or bone marrow/stem cell transplant.
• People who have a condition — whether present from birth or developed later — that causes their immune system to function poorly and leads to serious infections, or who are currently receiving regular immunoglobulin (antibody) replacement therapy.
• People who have had an active overlap condition such as mixed connective tissue disease or systemic sclerosis (another type of autoimmune disease) in the 12 months before or during screening, where that condition or its treatment could affect the study's results or safety assessments.
• People who have received B-cell depleting therapies (a type of treatment that targets certain immune cells), such as rituximab or obinutuzumab, within 6 months before screening; or any biologic medications such as belimumab or anifrolumab within 1 month before screening.
• People who are known to have had a severe allergic reaction to any of the study medications or their ingredients.
• People who have had a significant brain or nervous system condition unrelated to lupus in the 3 months before the first dose, such as stroke, epilepsy, severe brain injury, dementia, or serious psychiatric disorders.
• People with unstable or serious heart problems, including uncontrolled chest pain, recent heart attack (within 3 months), certain types of dangerous heart rhythm problems, significant heart failure, or uncontrolled high blood pressure.
• People with active bleeding.
• People with any active infection (except minor nail fungal infections), or who have a history of severe, recurring, or long-term infections.
• People who have been treated with intravenous (IV) antibiotics for an active infection within 14 days before screening (routine preventive antibiotic use is not excluded).
• People who test positive for HIV antibodies, have a history of active HIV infection, or test positive for syphilis antibodies at screening.
• People who test positive for active Hepatitis B (surface antigen positive). People with certain other Hepatitis B blood test patterns may still be considered, but would require ongoing monitoring during the study (confirm with trial site).
• People who test positive for Hepatitis C antibodies and have detectable Hepatitis C virus in their blood. People who have completed antiviral treatment and had no detectable virus for at least 6 months may still be considered, but would require ongoing monitoring (confirm with trial site).
• People who show signs of active tuberculosis (TB) at screening, have evidence of TB on chest imaging, or test positive for latent (inactive) TB infection.
• People who have had a cancer diagnosis within the past 5 years, with some exceptions for certain early-stage or fully treated cancers with no signs of return (confirm with trial site for specific exceptions).
• People who have previously received cell-based therapies such as CAR-T or CAR-NK therapy.
• Women who are pregnant or breastfeeding, or people of childbearing potential who are not using adequate contraception or who are planning to donate eggs or sperm.
• People who have any other serious or life-threatening health condition that the trial doctors believe could affect their safety or their ability to participate properly.

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