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 aged 5 years or older.
• People who have been diagnosed with systemic lupus erythematosus (SLE) using a recognised international classification system.
• People who have had at least one specific lupus-related antibody detected in a blood test within the past 12 months or at screening (antinuclear antibody at a level of 1:80 or higher, anti-double-stranded DNA antibody, or anti-Smith antibody above the normal range).
• People whose SLE has not responded well enough to at least three different treatments from the following groups: steroid tablets, antimalarial medicines, standard immune-suppressing medicines (such as cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, or leflunomide), or certain biologic medicines (such as belimumab or rituximab) — and at least one of those treatments must have been an immune-suppressing or biologic medicine.
• People with a disease activity score of 6 or higher on a standard lupus severity measurement tool called SLEDAI-2000.
• People currently taking one or more standard lupus treatments (steroid tablets, antimalarials, or immune-suppressing medicines) at a stable, unchanged dose for a set period before joining the trial.
• People whose blood test results meet specific minimum levels for immune cells, red blood cells, platelets, and certain markers of liver and kidney function (confirm with trial site for exact values).
• People whose heart function tests show the heart is pumping adequately, with no significant abnormalities on an electrical heart trace, and with blood oxygen levels of 92% or above.
• Women who could become pregnant must have a negative pregnancy test and must agree to use effective contraception during the trial and for one year after receiving the treatment.
• People (and their legal guardian, where applicable) who are willing and able to provide written consent after being informed about the study.

Who may not be able to join:

• People with active or unstable lupus affecting the brain or nervous system (such as seizures, confusion, or stroke-like events) within the past 60 days.
• People who have needed kidney dialysis or similar treatment within the past 3 months, or who the trial doctor believes may need high-dose steroids or strong immune-suppressing medicines for severe kidney disease within the first 3 months of the trial.
• People who have had a severe form of a clotting disorder called antiphospholipid syndrome within the past 12 months or at the time of screening.
• People with certain serious heart conditions, including a heart attack within the past 6 months, a congenital heart defect, dangerous heart rhythm problems, significant fluid around the heart, severe heart muscle inflammation, or those who need medicines to keep their blood pressure stable.
• People who have another condition that requires long-term use of steroids or immune-suppressing medicines.
• People who have an active or uncontrolled infection requiring treatment within one week before screening.
• People who have had an organ transplant or stem cell transplant within the past 3 months, or who have had a significant transplant rejection reaction (grade 2 or higher graft-versus-host disease) within the past 2 weeks.
• People with a history of severe, repeated, or ongoing infections, especially those affecting the lungs or breathing.
• People whose blood levels of a key immune protein (immunoglobulin G) are below the normal range for their age group.
• People with a current or past hepatitis B infection, HIV, active hepatitis C, or active cytomegalovirus or Epstein-Barr virus infection.
• People with a history of tuberculosis, active tuberculosis, untreated latent tuberculosis, or certain unclear tuberculosis test results that remain unclear on repeat testing.
• People who have had a serious immune system complication called macrophage activation syndrome within the past month.
• People who have received certain immune-targeting medicines (anti-CD19 or anti-CD20 therapies such as rituximab, obinutuzumab, ocrelizumab, or ofatumumab) within the past 3 months or during screening.
• People who are currently taking certain types of targeted medicines called JAK inhibitors, BTK inhibitors, or TYK2 inhibitors (such as baricitinib, tofacitinib, upadacitinib, ibrutinib, or zanubrutinib) during screening.
• People who have received cyclophosphamide or certain biologic medicines (such as adalimumab, belimumab, anifrolumab, or others in this group) within 4 weeks before joining.
• People who have a known allergy or serious sensitivity to monoclonal antibody medicines or to any ingredient in belimumab injection.
• People who have received a live vaccine within 4 weeks before screening.
• People with a positive blood pregnancy test.
• People who have a known cancer or malignant disease.
• People who have taken part in another clinical trial within the past 3 months.
• People with depression or thoughts of suicide.
• People the trial doctor considers unsuitable for participation for any other reason.

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