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:

• The person joining (or their legal guardian) must be willing and able to sign a consent form and follow all study requirements, appointments, and treatments
• Adults between 18 and 70 years old, of any gender
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE) — a type of autoimmune disease — at least 24 weeks before the screening visit, using recognised international diagnostic standards
• People whose SLE is moderate to severe or has not responded well to treatment, based on specific disease activity scores measured at screening, and who have already tried at least 12 weeks of standard SLE treatment without enough improvement
• People who are capable of having children must agree to use effective contraception throughout the study and for 3 months after the final follow-up visit

Who may not be able to join:

• People who have had a diagnosis of active severe lupus affecting the kidneys within the 8 weeks before screening, particularly if they required certain prohibited medications, dialysis, or high-dose steroid treatment for 14 days or more
• People who have attempted suicide or experienced thoughts of suicide at any point in the past year before screening
• People who have had brain or nervous system problems — whether related or unrelated to SLE — within the 8 weeks before screening
• People who have been diagnosed (previously or currently) with inflammatory joint conditions or skin diseases not caused by SLE
• People who have had a transplant of a major organ, bone marrow, or blood stem cells at any point
• People with a history of cancers affecting the lymph system (such as lymphoma)
• People who have been diagnosed with any cancer in the 5 years before screening
• People who have had plasma exchange, blood filtering, dialysis, or intravenous immunoglobulin (a blood-derived treatment) within the 14 days before screening
• People who have another autoimmune disease that requires ongoing whole-body (systemic) treatment
• People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis, or who have certain abnormal Hepatitis B blood test results
• People with active or latent (dormant) tuberculosis at the time of screening
• People with significant problems with how major organs (such as the liver or kidneys) are functioning at the time of screening
• People with serious ongoing illnesses unrelated to SLE that are not stable or well-controlled
• People who have severe lupus-related lung damage at the time of screening
• People who have severe lupus-related heart damage at the time of screening
• People with an active infection that cannot be controlled and requires antibiotic treatment at the time of screening
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before screening, or who plan to receive one at any point during the study
• People who have received steroid injections (into a joint, muscle, or vein) within 4 weeks before screening
• People who have taken certain targeted immune-suppressing medications known as JAK inhibitors or BTK inhibitors within 12 weeks before screening
• People who have previously received any treatment that targets B-cells (a type of immune cell)
• People who have received certain other biological treatments within a specific timeframe before screening (confirm exact timeframe with the trial site)
• People who have previously been treated with CAR-T cell therapy or other genetically modified T-cell therapies
• People who have received higher-dose steroid treatment within 7 days before the cell collection procedure, or within 72 hours before receiving the cell infusion
• People who have donated 400mL or more of blood, had significant blood loss, or received a blood transfusion within certain timeframes before screening, or who plan to donate blood during the study
• People who have had a significant bleeding episode within 4 weeks before screening, or who require ongoing blood-thinning (anticoagulant) medication
• People who have had major surgery within 12 weeks before screening, or who have major surgery planned during the study period
• People who have used recreational or illicit drugs within 12 weeks before screening
• Women who are pregnant or breastfeeding, or who intend to become pregnant within 2 years after receiving the cell treatment; male participants whose female partners intend to become pregnant within 2 years after the cell treatment
• People with a history of serious allergic reactions or significant intolerance to medications
• People who are currently participating in, or have participated in, another clinical trial within 3 months before screening (unless they did not receive any study treatment in that trial)
• People whom the research team considers unsuitable for any other reason

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