Phase 1 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 aged 16 to 55 years, either male or female
• People who have been diagnosed with systemic lupus erythematosus (SLE), a disease where the immune system attacks the body's own tissues, based on a specific set of international diagnostic guidelines, with a score of 10 or higher on that classification system
• People whose SLE is currently active enough to score 8 or higher on a standard disease activity measurement tool called SLEDAI-2K, with at least part of that score coming from blood or urine test results (not from brain or nervous system symptoms)
• People who have had certain immune-related markers detected in their blood — either antinuclear antibodies (ANA), anti-double-stranded DNA antibodies, or anti-Sm antibodies — either at screening or recorded in their medical history
• People whose SLE has not responded well enough to standard treatments, meaning the disease was not adequately controlled after at least 6 months of treatment with steroids, hydroxychloroquine, and at least two other immunosuppressive medicines (confirm with trial site)
• OR people who have a specific form of kidney disease caused by lupus (called lupus nephritis) that has continued to be active after two separate courses of standard kidney treatments, each lasting at least 6 months, AND whose kidney disease has been confirmed by a tissue sample (biopsy) showing a particular level of severity, AND who have significant protein loss in their urine (confirm with trial site)
• People whose liver is functioning within acceptable limits, based on blood tests
• People whose lungs are functioning at 60% or more of the expected level, based on breathing tests
• People whose heart is pumping well enough (at least 50% efficiency), with no uncontrolled irregular heartbeat, no blood clots in the heart, and no heart failure
• People whose blood counts meet minimum safety levels — including white blood cells, infection-fighting cells, platelets, and red blood cells — without needing medication to boost those levels
• People who are able and willing to sign a written consent form agreeing to take part
• People of reproductive potential who agree to use effective contraception throughout the study period

Who may not be able to join:

• People with a history of significant brain or nervous system conditions, such as traumatic brain injury, seizure disorders, bleeding in the brain, or seriously impaired consciousness
• People who have had a significant heart or blood pressure problem in the 3 months before screening, such as a heart attack, unstable chest pain, severe irregular heartbeat, or severe heart failure
• People who have previously had a kidney transplant
• People with severe asthma requiring long-term treatment, or who have experienced respiratory failure
• People with severe destruction of red blood cells (haemolytic anaemia) that requires a blood transfusion every 7 days or more frequently
• People with active viral infections, including hepatitis B or C, HIV, tuberculosis, malaria, syphilis, or certain other viral infections, or any other life-threatening infectious illness
• People with a currently active bacterial infection confirmed by examination, imaging, or blood tests
• People who have recently received certain treatments before a procedure called leukapheresis (a process to collect immune cells from the blood), including anti-CD20 medicines, cyclophosphamide, or live vaccines within the past month; or steroids above a certain dose, certain immune-suppressing medicines, or antimalarial medicines within the past 7 days (confirm with trial site for specific timeframes)
• People who have previously received anti-CD19 therapy
• People who have previously received any T-cell-based cell therapy or gene therapy, including CAR-T cell therapy
• People who currently have or have previously had any cancer
• People who are known to have an allergic reaction to any of the medicines or agents used in this study
• Women who are pregnant or breastfeeding
• People with active antiphospholipid syndrome, a condition where the immune system increases the risk of blood clots (note: having the associated antibodies in the blood without active disease may be permitted — confirm with trial site)
• People who are currently taking part in another clinical trial
• People whose overall health situation, in the treating doctor's judgement, would make it difficult to safely follow the study procedures

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