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:

• People who have been diagnosed with systemic lupus erythematosus (SLE) based on recognised 2019 classification standards.
• People whose lupus is currently rated as moderately to severely active, based on a standard disease activity scoring tool called SLEDAI-2000 (score above 6).
• People whose lupus is affecting at least one organ system severely, or two organ systems moderately, as measured by a medical assessment tool called BILAG-2004.
• People whose lupus has not responded to standard treatments, or whose disease has come back after a period of remission — where standard treatment means corticosteroids at a certain dose combined with cyclophosphamide and at least one other immune-suppressing medication taken for more than 6 months (such as hydroxychloroquine, azathioprine, mycophenolate mofetil, methotrexate, or similar medicines, and/or biologics such as rituximab or belimumab).
• People aged between 18 and 65 years; both males and females are eligible.
• People whose blood counts, liver, kidneys, heart, and clotting function all meet specific minimum levels set by the trial (confirm with trial site for exact values).
• People who agree to use effective contraception throughout the study and for one year after completing the study treatment.
• Women who could potentially become pregnant must have a negative pregnancy blood test within 7 days before joining, and must not be breastfeeding.
• People who are willing to take part voluntarily, sign a consent form, and attend all required follow-up appointments.

Who may not be able to join:

• People who have lupus affecting the nervous system or brain (known as neuropsychiatric lupus).
• People with a history of a blood-clotting disorder affecting small blood vessels (thrombotic thrombocytopenic purpura or thrombotic microangiopathy).
• People with a history of severe allergic reactions to medications.
• People with an active or suspected infection that is not under control and requires treatment (including fungal, bacterial, viral, or other types of infection).
• People with a disorder affecting the central nervous system (brain or spinal cord), whether caused by an autoimmune condition or another cause.
• People with serious heart disease.
• People born with a condition that means their immune system cannot produce normal antibodies (congenital immunoglobulin deficiency).
• People with a history of cancer, except for certain early-stage or treated skin or other cancers where the person has been cancer-free for more than 5 years (confirm with trial site).
• People with end-stage kidney failure.
• People who test positive for active Hepatitis B, active Hepatitis C, HIV, or syphilis (as defined by specific test results — confirm with trial site for details).
• People with a psychiatric condition or significant memory or thinking impairment.
• People who have taken part in another clinical trial within the 3 months before joining this one.
• People who are pregnant or who are planning to become pregnant during the study period.
• People whom the trial doctor determines should not participate for any other medical or safety reason.

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