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:

• You are able to understand and are willing to sign a consent form agreeing to take part
• You are aged 18 to 75 years old (any gender)
• Doctors expect you to live for more than 6 months
• You have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) using the 2019 EULAR/ACR guidelines
• Your lupus is considered moderate to severe, based on a specific scoring system used at your screening visit
• Your current lupus treatment plan has been stable for at least 30 days before joining the trial
• Certain blood test results at screening show markers associated with lupus activity (confirm with trial site)
• A specific type of immune cell (CD19+ B cell) is present in your blood
• Your organ function meets the required levels before starting treatment (confirm with trial site)
• If you could become pregnant or could father a child, you are willing to use highly effective contraception from 7 days before the first dose until 24 weeks after treatment ends, and not donate eggs or sperm for 1 year after the last treatment
• If you could become pregnant, you have a negative pregnancy test within 7 days before the first dose
• You are able and willing to attend all required visits and follow the trial schedule

Who may not be able to join:

• You had a severe lupus kidney flare in the 8 weeks before screening
• You had an uncontrolled, severe lupus crisis in the 8 weeks before screening
• You experienced active brain-related symptoms or psychosis related to lupus in the 6 months before screening
• Your main diagnosis is a different autoimmune or inflammatory condition (not lupus)
• You received a treatment specifically designed to deplete B cells in the 6 months before starting the trial drug
• You received CAR-T cell therapy in the 6 months before starting the trial drug
• You used certain biologic medicines that target immune signalling proteins (cytokines) within 12 weeks before dosing
• You used anti-TNF (anti-tumour necrosis factor) medications within 8 weeks before dosing
• You used a JAK inhibitor medication within 2 weeks before dosing
• You took part in another clinical trial or used an experimental drug within 28 days before dosing (or within 5 half-lives of that drug)
• You have had a major organ transplant, or a stem cell or bone marrow transplant
• You have active Hepatitis B, Hepatitis C, HIV, or syphilis
• You have had a significant heart or cardiovascular condition in the 6 months before screening (confirm with trial site for full details)
• Your blood pressure is poorly controlled (top number 160 or higher, or bottom number 100 or higher)
• You have an abnormal heart rhythm measurement on an ECG called a prolonged QT interval (confirm with trial site)
• You have had a significant bleeding episode in the 30 days before screening, or you need ongoing blood-thinning medication
• You have had an allergic reaction to similar types of medicines (recombinant humanised antibodies) or to any ingredient in the trial drug
• You are currently pregnant or breastfeeding
• You have had thoughts of suicide in the 6 months before signing the consent form, considered significant by the research team
• You have been diagnosed with cancer within the last 5 years
• You have had your spleen removed
• You have had problems with alcohol or drug misuse in the 12 months before screening, as judged by the research team
• You have an active infection currently requiring antibiotic treatment, or had one within 2 weeks before screening
• You have a history of a severe or widespread viral infection
• You may have an active tuberculosis (TB) infection

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