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:

• People aged 18 to 65 years old (any gender)
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE, also known as lupus) based on recognised 2019 international classification guidelines, with certain specific antibody markers present in their blood
• People whose lupus has become active again after standard treatments have not worked, or whose disease has come back despite treatment — where standard treatment means using two or more medications (including high-dose steroids and at least one other immune-suppressing drug such as antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics like rituximab or belimumab) for more than six months
• People whose lupus disease activity meets certain scoring thresholds on two recognised lupus measurement scales (BILAG2004 and SELENA-SLEDAI) (confirm with trial site)
• People who show a certain marker on their B cells (immune cells in the blood), confirmed by a specific blood test (confirm with trial site)
• People whose blood cell counts, liver function, kidney function, blood clotting, and heart function all meet specific minimum levels as tested (confirm with trial site)
• Women of childbearing age who have a negative pregnancy blood test within 7 days before joining the study and are not breastfeeding
• People (and male participants whose partners could become pregnant) who are willing to use medically accepted contraception or abstain from sex for at least 6 months after receiving the study treatment
• People who are willing to sign a consent form, attend all follow-up visits, and complete the study as required

Who may not be able to join:

• People with a serious history of drug allergies or who are known to have a highly allergic constitution
• People who have an active or suspected infection caused by bacteria, fungi, viruses, or other sources that is not under control or requires intravenous antibiotics or other intravenous treatments
• People who have active disease affecting the brain or central nervous system, whether caused by lupus or another condition (including epilepsy, psychosis, stroke, encephalitis, or inflammation of blood vessels in the brain)
• People with significant heart conditions such as angina, heart attack, heart failure, or serious irregular heartbeat
• People born with a condition that means their immune system cannot produce immunoglobulins (certain immune proteins)
• People who have or have had another cancer, with the exception of certain skin cancers, cervical cancer in early stage, bladder cancer, or breast cancer where the person has been disease-free for more than 5 years
• People with end-stage kidney failure
• People who have recently received certain lupus treatments, including: high-dose steroids within 72 hours before the study treatment; other experimental SLE drugs within 4 weeks before joining; the antibody drug rituximab within 4 weeks, or certain other specific biologics within 6 to 12 weeks before screening (confirm exact timeframes with trial site)
• People who have previously received CAR-T cell therapy or any other genetically modified T cell therapy
• People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis, with certain specific blood test results (confirm with trial site)
• People who have a mental illness or severe difficulties with thinking and memory
• People who have taken part in another clinical trial within 3 months before joining this study
• Women who are pregnant or planning to become pregnant
• People considered unsuitable for the trial by the treating doctor for any other reason

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