Phase 2 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 who (or whose guardians) are able to understand and sign a consent form, and are willing to attend all required visits and follow all study procedures
• People aged 18 to 70 years old, of any gender
• People who weigh at least 40 kg (about 88 pounds)
• People who were diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) at least 24 weeks before joining the study, using a recognised set of medical criteria
• People whose SLE is currently active, as measured by specific scoring tools used by doctors (confirm with trial site for exact score thresholds)
• People who have already received at least 8 weeks of standard SLE treatment before the screening visit
• Female participants whose pregnancy test comes back negative, and who agree to use effective contraception for the whole duration of the study

Who may not be able to join:

• People with a known allergy or sensitivity to prednisone or immunosuppressive medicines
• People who have been diagnosed with severe active lupus affecting the kidneys in the 8 weeks before screening, and who require certain high-dose medications or kidney dialysis as a result
• People who have had thoughts of suicide in the past 6 months, any suicidal behaviour in the past 12 months, or repeated suicidal behaviour at any point in their life (as assessed using a standard rating scale)
• People who have had SLE-related or other central nervous system (brain or spinal cord) disease or changes in the 8 weeks before screening
• People who have experienced another serious lupus-related crisis in the 8 weeks before screening
• People who have been diagnosed with inflammatory joint or skin conditions not related to SLE
• People who have been diagnosed with severe blood vessel inflammation caused by a condition other than SLE
• People who have had a major organ transplant, or a bone marrow or stem cell transplant at any point
• People who have received plasma exchange, kidney dialysis, or intravenous immunoglobulin treatment within 14 days before screening
• People who have another autoimmune condition that requires ongoing systemic (whole-body) treatment
• People who test positive for active Hepatitis B, Hepatitis C antibodies, HIV antibodies, cytomegalovirus (CMV), Epstein-Barr virus (EBV), or syphilis
• People with active or latent tuberculosis at screening (though people who have already been appropriately treated may still be considered — confirm with trial site)
• People with severely abnormal results in liver, kidney, bone marrow, blood clotting, lung, or heart function tests at screening
• People with a history of severe allergic reactions to any ingredients in the trial drugs, including any products derived from rodents or animal proteins, or people known to have a generally highly allergic constitution
• People with severe heart disease
• People with severe liver or bile duct disease
• People with other medical conditions that are clearly unstable or not well managed
• People with an uncontrolled infection (bacterial, fungal, viral, or other) that requires antibiotic treatment
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before screening, or who plan to receive one during the study
• People who have recently taken certain types of targeted medicines known as JAK inhibitors or BTK inhibitors (within a specific time window before screening — confirm with trial site)
• People who have previously received B-cell targeted therapy at any point
• People who have received certain biological medicines (other than B-cell targeted therapy) within a specific time window 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 taken high-dose steroid medicines within 7 days before a cell collection procedure, or within 72 hours before a cell infusion
• People who have taken any other experimental SLE medicines within 4 weeks before the cell collection procedure
• People who have had major surgery within 4 weeks before the lymph depletion stage of the study, who are scheduled for major surgery during the study, or whose surgical wounds have not fully healed before joining
• People who have donated 400 mL or more of blood or had significant blood loss within 4 weeks before screening, received a blood transfusion within 8 weeks before screening, or plan to donate blood during the study
• People who have had a significant bleeding event (grade 2 or higher) within 4 weeks before screening, or who need long-term blood-thinning medication
• People with severe mental illness
• People with alcohol dependency or a history of substance abuse
• Female participants who are pregnant or breastfeeding, or who plan to become pregnant within 2 years after the cell infusion; male participants whose female partners plan to become pregnant within 2 years after the cell infusion
• People with a history of cancer (malignancy)
• People with any other medical condition that, in the treating doctor's judgement, would make participation unsafe

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