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 between 18 and 75 years old at the time of signing the consent form
• You have been diagnosed with Systemic Lupus Erythematosus (SLE) using recognised medical classification guidelines
• Certain specific lupus-related antibodies have been found in your blood tests at screening (confirm with trial site)
• Your lupus disease activity scores meet a minimum level of severity as measured by a standard lupus scoring tool (confirm with trial site)
• Your current lupus treatments have not worked well enough for at least 3 months before the screening visit
• You have been on a stable combination of treatments for a set period before joining
• If you have active lupus kidney disease specifically, it must be a particular type (Class III or IV) as confirmed by your doctor

Who may not be able to join:

• Your blood or lab test results at screening fall outside acceptable ranges
• You currently have an active infection
• You are taking certain medications that are not allowed in this trial and cannot stop taking them
• You received a live vaccine within 4 weeks before your screening visit
• You have another autoimmune disease alongside lupus
• You have a serious blood-clotting condition called catastrophic antiphospholipid syndrome, either currently or with a known history
• You have antiphospholipid syndrome or a blood clot that is not well controlled by blood-thinning medication
• You have a history of a serious brain condition called progressive multifocal leukoencephalopathy
• You have a history of a primary immune system disorder or an inherited deficiency affecting a part of your immune system called the complement system
• You have a disease affecting your central nervous system (brain or spinal cord)
• You have one or more other serious ongoing medical conditions (confirm with trial site)
• You have been diagnosed with or treated for cancer within the last 5 years
• You have a serious mental health condition, alcohol or drug dependency, dementia, or any condition that would affect your ability to participate or give informed consent
• You are unable or unwilling to follow the requirements set out in the trial plan
• You have had a severe allergic or anaphylactic reaction to a type of medicine called monoclonal antibody therapy, or to any ingredient in the trial drug (cizutamig)
• You have had an organ transplant or stem cell transplant in the past, or one is planned
• You have had major surgery requiring general anaesthesia within the last 12 weeks, or major surgery is planned during the trial
• You are currently pregnant or breastfeeding
• You are unwilling to use highly effective contraception as required by the trial
• You are considered part of a vulnerable population, such as being incarcerated

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