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 are between 18 and 70 years old
• You have been diagnosed with Systemic Lupus Erythematosus (SLE/Lupus) and scored at least 10 points on a standard lupus classification scoring system
• Your lupus has not been adequately controlled despite trying at least two immunosuppressant medications and/or at least one approved biological treatment for more than 6 months
• Your lupus disease activity score (SELENA-SLEDAI) is 8 or higher, meaning your lupus is currently quite active
• You have a certain type of immune cell (CD19+ B-cell) present in your blood
• Your blood counts and organ function meet minimum safe levels — including haemoglobin, white blood cells, neutrophils, and platelets (confirm specific values with trial site)
• Your liver, kidney, and heart function are within acceptable ranges as shown by blood tests and a heart scan
• You have suitable veins for a blood-filtering procedure and no reasons that would prevent it
• If you are a woman who could become pregnant, you have a negative pregnancy test and agree to use effective contraception for at least 1 year after treatment
• You agree to attend all required follow-up appointments
• You are willing to take part and have signed (or your legal representative has signed) an informed consent form

Who may not be able to join:

• You have severe kidney disease related to lupus, or you need dialysis
• You have a nervous system or brain condition related to lupus, such as epilepsy, psychosis, stroke, encephalitis, or depression with thoughts of suicide
• You have serious damage to or a history of major problems with your heart, liver, kidneys, blood, or hormone-producing glands
• You have a weakened immune system, an uncontrolled active infection, or active or recurring stomach/intestinal ulcers
• You received immunosuppressant medication within 1 week before the blood-filtering procedure
• You have HIV, active hepatitis B or C, or syphilis
• You have an active fungal, bacterial, viral, or other infection that cannot be controlled at the time of screening
• You received a live vaccine within 4 weeks before screening
• You have a history of severe allergic reactions
• You have a medical reason that prevents you from receiving the preparatory medications used in this treatment (cyclophosphamide and fludarabine) (confirm with trial site)
• You had major surgery within 2 weeks before signing consent, or are expected to need surgery during the trial or within 2 weeks of receiving the treatment
• You have a tube or drain in your body other than a central venous catheter (confirm with trial site)
• You are pregnant, breastfeeding, or plan to have children within 1 year of treatment
• You have previously received treatment targeting CD19 or BCMA (certain types of targeted immune therapies)
• You have taken part in another clinical trial within the past 3 months
• You have or have had a malignant cancer — with some possible exceptions including certain early-stage or treated cancers such as non-melanoma skin cancer (disease-free for over 5 years), cervical cancer in situ, bladder cancer, or breast cancer (confirm with trial site)
• The trial doctors have any other concern that makes participation unsuitable for you

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