Phase 1 Vasculitis 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 who have personally signed a consent form approved by the Ethics Committee before the study begins

• People aged 18 to 65 years old

• People with one of the following kidney or immune conditions (see details below):

  Lupus Nephritis (LN): People with an active, returning, or treatment-resistant form of lupus that affects the kidneys, confirmed by a kidney biopsy in the last 2 years showing a specific type (III, IV, or V), with a disease score within a certain range, whose kidneys are still functioning at a moderate level (confirm with trial site), who have significant protein in their urine, and whose overall lupus disease activity score meets a minimum threshold — and whose lupus either did not respond to at least 6 months of standard treatment, or has returned and required higher steroid doses to control

  ANCA-associated vasculitis (AAV): People diagnosed with a specific type of blood vessel inflammation (AAV) that affects the kidneys, either newly diagnosed (with a kidney biopsy showing a specific pattern and high levels of red blood cells in the urine), or with a condition that has returned or not responded to standard treatment based on specific disease activity scores

  Membranous Nephropathy (MN): People diagnosed by tissue biopsy with a specific antibody-related kidney condition (aPLA2R-related), who are considered high-risk (based on kidney function, urine protein levels, blood protein levels, or specific antibody levels after treatment), or whose condition has not responded to or has returned after immunosuppressive treatment, and whose kidneys are still functioning at a moderate level

  IgG4-related disease: People meeting the 2019 international diagnostic criteria for IgG4-related disease, either newly diagnosed with active disease (based on a specific activity score), or with a condition that has not responded to or has returned after steroid-based treatment

• People expected to survive at least 12 weeks

• People with a general health and activity level within an acceptable range, as measured by a standard medical scale (ECOG score of 2 or below)

• Women who are able to become pregnant and agree to use highly effective contraception from the time of signing consent until 365 days after the treatment infusion

• People with blood counts and organ function meeting specific minimum levels before joining (confirm exact thresholds with trial site)

Who may not be able to join:

• People who have previously received gene therapy
• People who received a live vaccine within 4 weeks before joining
• People who received another experimental drug treatment within 12 weeks before a blood-filtering procedure (apheresis)
• People with an active cancer diagnosed in the past 5 years, except for certain types considered fully cured (such as specific skin cancers or early-stage cervical or breast conditions)
• People with certain active hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis infections, based on blood test results
• People with active infections that are not under control (with limited exceptions for minor urinary or upper respiratory infections)
• People with serious heart conditions, including unstable chest pain, a heart attack within the past 6 months, significant heart failure, or severe irregular heartbeat
• People with high blood pressure or diabetes that cannot be managed with medication
• People who still have significant side effects from previous treatments that have not resolved
• People who had major surgery within 2 weeks before joining, or who plan to have major surgery while waiting for or within 12 weeks after the study treatment (minor procedures under local anaesthetic may be acceptable — confirm with trial site)
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant)
• Women who are pregnant or breastfeeding
• People with a history of certain brain or nervous system conditions, such as stroke, epilepsy, dementia, or psychosis
• People with other serious, unstable conditions affecting the liver, kidneys, digestive system, or metabolism that require medication
• People known to have a serious allergic reaction or intolerance to the study treatment (FKC289) or its components
• People with serious bleeding disorders, clotting conditions, or those currently on blood-thinning or clot-dissolving medication
• People who received B cell-targeting therapies within the past 6 months
• People who received high-dose steroid pulse therapy or cyclophosphamide pulse therapy within the past month
• People whose doctors determine they cannot stop other immune-suppressing medications one week before the blood-filtering procedure, or who are taking more than a low daily dose of steroids (above a small threshold — confirm with trial site)
• People with a specific subtype of AAV called eosinophilic granulomatosis with polyangiitis, or who have active bleeding in the lungs
• People whom the treating doctor considers unsuitable for any other reason

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