Phase 2 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 who are willing to give informed consent (or whose guardian gives consent on their behalf) and are able to attend all required visits, tests, and treatments throughout the study
• Adults aged 18 to 70 years old, of any gender
• People who weigh at least 40kg
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) for at least 24 weeks before joining the study, using a recognised set of medical criteria
• People whose SLE is currently active, meaning their disease activity scores meet specific thresholds at the screening stage (confirm with trial site)
• People who have already been on a standard SLE treatment plan for at least 8 weeks before screening
• Female participants whose pregnancy test is negative, and all participants who agree to use effective contraception for the entire duration of the study

Who may not be able to join:

• People who have a known allergy or sensitivity to prednisone or immunosuppressive medications
• People diagnosed with a severe, active form of lupus affecting the kidneys in the 8 weeks before screening, particularly those who required specific high-dose steroid treatments, kidney dialysis, or medications not permitted in this study
• People who have experienced suicidal thoughts in the past 6 months, any suicidal behaviour in the past 12 months, or repeated suicidal behaviour at any point in their lifetime, as assessed by a standard screening tool
• People who have had SLE-related or non-SLE-related brain or nervous system conditions in the 8 weeks before screening
• People who have experienced another type of severe lupus flare-up (lupus crisis) in the 8 weeks before screening
• People who have been previously or are currently diagnosed with inflammatory joint disease or skin conditions not related to SLE
• People who have been previously or are currently diagnosed with severe inflammation of the blood vessels caused by a disease other than SLE
• People who have had a transplant of a major organ, or a bone marrow or stem cell transplant
• People who have had plasma exchange, kidney dialysis, or intravenous immunoglobulin treatment in the 14 days before screening
• People who have another autoimmune disease that requires ongoing whole-body (systemic) treatment
• People with active or latent (hidden) tuberculosis at the time of screening, unless it has already been appropriately treated
• People with seriously abnormal test results for liver, kidney, bone marrow, blood clotting, lung, or heart function at screening
• People with a known severe allergy to any ingredient, inactive substance, or animal-derived component used in the trial's treatments
• People with serious heart disease
• People with serious liver or bile duct disease
• People with other medical conditions that are clearly unstable or not being effectively managed
• People with an active infection (bacterial, fungal, viral, or other) that is not under control and currently requires antibiotic treatment
• People who have received a live or weakened (attenuated) vaccine in the 4 weeks before screening, or who plan to receive one during the study
• People who have recently received certain types of targeted immune medications known as JAK inhibitors or BTK inhibitors (within a specific timeframe before screening — confirm with trial site)
• People who have previously received a type of treatment that targets B-cells
• People who have recently received a biological therapy (other than B-cell targeted therapy) within a specific timeframe before screening (confirm with trial site)
• People who have previously been treated with CAR-T cell therapy or other genetically modified T-cell therapies
• People who have received high-dose steroid treatment within 7 days before a cell collection procedure, or within 72 hours before a cell infusion
• People who have had major surgery in the 4 weeks before the treatment preparation stage, who are scheduled for major surgery during the study, or whose surgical wounds have not fully healed at the time of joining
• People who have donated 400mL or more of blood or had significant blood loss in the 4 weeks before screening, received a blood transfusion in the 8 weeks before screening, or plan to donate blood during the study
• People who have had a significant bleeding episode in the 4 weeks before screening, or who need ongoing anticoagulant (blood-thinning) medication
• People with severe mental illness
• People with a history of alcohol dependency or drug misuse
• Female participants who are pregnant or breastfeeding, or who plan to become pregnant within 2 years after receiving the cell infusion; male participants whose female partners plan to conceive within 2 years after the cell infusion
• People with a history of cancer
• People with any other medical condition or contraindication that, in the judgment of the medical team, would put them at unacceptable risk

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