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 are able to give voluntary written consent to participate and follow the study requirements
• Adults aged 18 to 60 years at the time of screening
• People diagnosed with Systemic Lupus Erythematosus (SLE, a chronic immune system disease) that has come back or not responded to treatment, with at least 6 months of disease history, a confirmed SLE diagnosis using recognised medical criteria, a disease activity score meeting a set threshold, and a poor response to at least two standard treatments including steroids and immune-suppressing medicines
• People with SLE who have been on a stable treatment plan (which may include anti-inflammatory drugs, immune-suppressing medicines, or steroids at a specific dose range) for at least 8 weeks before screening, and who have previously used at least two immune-suppressing medicines including hydroxychloroquine
• People with SLE who are expected to live for more than 6 months
• People with a blood condition called Autoimmune Haemolytic Anaemia (AIHA) or Evans syndrome who have tried and not responded to at least three different lines of treatment — including steroids, rituximab, and at least one additional treatment (confirm with trial site for full details)
• People with AIHA who are expected to live for more than 3 months
• People whose kidneys, bone marrow, liver, and lungs are functioning at or above minimum levels set by the trial (confirm with trial site for specific test values)
• Women who are not pregnant or breastfeeding, and who are either surgically unable to have children, have been through menopause for at least 2 years, or agree to use effective contraception during the study and for at least 12 months after the last dose, and agree not to breastfeed during that time
• Men who are not surgically sterile and are sexually active in a way that could lead to pregnancy must agree to use effective contraception during the study and for at least 12 months after the last dose, and must agree not to donate sperm during that period

Who may not be able to join:

• People who have a thymoma (a type of tumour near the chest) that has not been removed
• Women who are pregnant or currently breastfeeding
• People with a history of serious or unstable neurological or psychiatric SLE symptoms, such as poorly controlled seizures, psychosis, confusion, stroke, or active inflammation of blood vessels in the brain
• People with significant existing brain or nervous system conditions such as stroke, epilepsy, dementia, Parkinson's disease, severe brain injury, or psychosis
• People who have had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell or bone marrow transplant
• People with an active infection at the time of screening, including active tuberculosis, pneumonia, hepatitis B or C with detectable virus, HIV, syphilis with active infection, or a history of shingles (herpes zoster) within the past 12 weeks, or who have needed hospital treatment or antibiotics recently
• People who have had certain heart conditions within the past 6 months, including heart failure, heart attack, unstable chest pain, certain abnormal heart rhythms, or who have abnormal heart test results at screening
• People who have had a cancer diagnosis within the past 5 years, with some exceptions for certain low-risk or fully treated skin and localised cancers (confirm with trial site for full details)
• People who have recently received certain targeted biological medicines (such as belimumab, rituximab, or similar drugs) within a set timeframe before screening
• People who have taken another experimental drug for SLE in a clinical trial within the past 4 weeks
• People with other serious conditions affecting the liver, nervous system, hormonal system, or blood, which in the investigator's judgement would affect safe participation
• People who have recently received intravenous immunoglobulin, plasma exchange, or certain experimental non-biological drugs (such as BTK or JAK inhibitors) within 4 weeks or 5 half-lives before screening, whichever is shorter
• People who have received a vaccine within 30 days before the first dose of the study drug
• People who have been treated with an mRNA-LNP or similar lipid nanoparticle-based drug within the past 2 years before the first dose
• People with a history of asthma, severe allergic reactions, or a known allergy to any ingredient in the study drug
• People who have previously received CAR-T cell therapy
• People who have had major surgery within 4 weeks, or minor surgery within 2 weeks, before the first dose of the study drug
• People with a severe mental health disorder or signs of suicidal tendencies
• People who, in the investigator's judgement, are considered unsuitable for the study for any other reason

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