Phase 2 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 are able and willing to give written consent to participate before any study procedures begin
• People who are 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to recognised international medical definitions
• People who have had a positive blood test result for certain antibodies (called PR3, MPO, cANCA, or pANCA) at some point — even if those tests are currently negative
• People whose vasculitis condition is currently active (within 6 weeks of the screening visit), and whose disease has either returned after a period of remission (relapsed), or has not responded to standard treatment for at least 6 weeks (refractory)
• People whose active vasculitis is classified as severe, based on specific disease activity measures, certain types of organ or tissue involvement, or agreement among a panel of medical experts
• People whose heart is pumping at more than 45% of its normal capacity, as measured by a specific heart test
• People whose liver is functioning adequately, based on specific blood test results being within an acceptable range (confirm with trial site)
• People whose kidneys are functioning at a sufficient level, based on a calculated kidney filtration rate above a specific threshold (confirm with trial site)
• People with a sufficient level of a certain type of white blood cell (lymphocytes) in their blood
• People with adequate levels of haemoglobin (a measure of red blood cells) and platelets (cells that help blood clot) in their blood
• People who are willing to use effective contraception starting before a blood collection procedure and continuing for at least 12 months after treatment, due to unknown risks to an unborn child or infant
• People who are willing and able to attend all required study visits and follow the study requirements

Who may not be able to join:

• People who have ever tested positive for a particular antibody that targets the kidney's filtering membranes (glomerular basement membrane antibody)
• People whose vasculitis is believed to have been caused by a medication, cocaine, or a substance called levamisole sometimes found in cocaine
• People who have already been treated with rituximab or a similar medicine specifically for their current episode of relapsing vasculitis (prior use for a previous episode is acceptable)
• People who have Parkinson's disease, epilepsy, difficulty speaking or understanding language (aphasia), or disease affecting balance and coordination (cerebellar disease)
• People who have previously received an organ transplant and are currently taking medicines to prevent rejection of that organ
• People who currently have an active cancer being treated, other than certain non-spreading skin cancers
• People who have previously received any CAR T cell therapy
• People who have another serious health condition that the lead doctor believes would put them at unnecessary risk or affect the study results
• People who have an active infection (bacterial, viral, or fungal) that is not under control
• People who have a history of moderate to severe heart failure (classified as class III or IV), or a history of a certain type of heart muscle disease not caused by blocked arteries
• People who have had unstable chest pain, a heart attack, or serious irregular heart rhythms requiring treatment in the past 3 months
• People with a high risk of bleeding, based on specific blood clotting test results being above a certain level, unless this is due to a stable anticoagulant (blood-thinning) medication
• People with a very low level of a type of white blood cell called neutrophils in their blood
• People with active symptoms from blood vessel disease affecting the brain or limbs, who require ongoing blood-thinning or dual antiplatelet medication that cannot safely be paused (confirm with trial site)
• People who have had a blood clot in the lungs or a deep vein clot within the past 6 months before a preparatory chemotherapy step, and who still require ongoing blood-thinning treatment
• People who are currently pregnant or breastfeeding, due to potential risks to a developing baby or infant from the study treatment

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