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 between 18 and 75 years old, of any gender
• People who have been diagnosed with active lupus (SLE) that has not responded well to previous treatments, confirmed using recognised medical criteria for at least 24 weeks, with a high disease activity score at the time of screening
• People whose lupus has previously been treated with standard steroid medicines and at least two other types of immune-modifying treatments (such as immunosuppressants, antimalarial drugs, or biologics) for at least 3 months
• People who test positive for at least one of the following lupus-related antibodies in their blood: ANA, anti-dsDNA, or anti-Smith
• People taking low-dose steroid tablets (up to 20mg prednisone or equivalent per day) at a stable dose for at least 2 weeks before the screening visit
• People taking antimalarial medication (such as hydroxychloroquine, up to 400mg per day) who have been on a stable dose for at least 8 weeks, provided the treatment was started at least 12 weeks before screening
• People taking immunosuppressant medicines at a stable dose for at least 4 weeks before screening
• People whose blood test results meet specific minimum thresholds for white blood cells, red blood cells, platelets, and liver function markers (confirm exact values with trial site)
• People (and their partners) who agree to use effective contraception from the time of signing the consent form until one year after receiving the study treatment
• People who are willing and able to sign an ethics-approved consent form before any screening procedures begin

Who may not be able to join:

• People whose lupus was caused by a medication (drug-induced lupus)
• People who also have another autoimmune condition, such as Sjögren's syndrome, psoriasis, or rheumatoid arthritis, that could affect study results
• People who have had a severe or catastrophic antiphospholipid syndrome episode within the past year, or who have ever had a catastrophic antiphospholipid syndrome
• People whose lupus has caused severe neurological symptoms rated at the highest activity level on a standard medical scoring system
• People with a known primary immune deficiency condition (present from birth or developed over time)
• People with an active infection that has not improved with treatment, or who currently need intravenous antibiotics or antiviral medicines
• People who test positive for hepatitis B, hepatitis C (with active virus detected), HIV, cytomegalovirus (CMV), or syphilis
• People with serious heart conditions, including unstable chest pain or heart attack within the past 12 months, significant heart failure, severe heart rhythm problems, or reduced heart pumping function below a certain level
• People with severe asthma or chronic obstructive pulmonary disease (COPD), or low blood oxygen levels at rest
• People assessed by the trial doctor as having a serious risk of bleeding
• People assessed by the trial doctor as having severely reduced liver function
• People with a history of serious kidney disease, or whose kidney function falls below a certain level based on a standard calculation
• People who have had a stroke or mini-stroke (transient ischaemic attack) within the 6 months before joining
• People with any other serious or uncontrolled health condition, as assessed by the trial doctor
• People who have had a cancer diagnosis within the past 5 years (certain fully treated early-stage cancers may be exceptions — confirm with trial site)
• People with a known significant mental health disorder or a history of substance abuse that has not been resolved
• People with a known allergy to any components of the study treatment (IASO207) or to medicines used to manage side effects of this type of therapy, such as tocilizumab
• People who have previously had an organ transplant
• People who have previously had a stem cell transplant (either their own cells or a donor's)
• People who have previously received a cell therapy treatment or any medicine that targets the CD19 protein
• People who received certain targeted lupus biologic therapies (such as rituximab or obinutuzumab) within the 12 weeks before screening
• People who received plasma exchange or immunoadsorption treatment within the 12 weeks before screening
• People who had major surgery, or are planning major surgery, within 12 weeks before or after screening
• People who have taken part in another clinical drug trial within the past 4 weeks, or within 5 half-lives of the other trial drug (whichever is longer)
• People who have received a BAFF antagonist medicine (such as belimumab or tixagevimab) within the past 4 weeks
• People who have received a live attenuated vaccine within the past 4 weeks
• Women who are pregnant or breastfeeding
• People considered unsuitable for the trial for any other reason, as determined by the trial investigators

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