Early 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 voluntarily agreed to take part and have signed a consent form
• People aged between 18 and 70 years old (any sex)
• People whose liver function blood test results are within an acceptable range (confirm with trial site)
• People whose kidney function test results are within an acceptable range (confirm with trial site)
• People whose blood cell counts — including white blood cells, red blood cells, and platelets — are within an acceptable range (confirm with trial site)
• People whose blood clotting test results are within an acceptable range (confirm with trial site)
• People whose blood oxygen level is at least 92% while resting and breathing normal air
• People whose heart pumping function (measured by an ultrasound of the heart) is at least 50%
• Women who could become pregnant must have a negative pregnancy test at the start of the study
• Women who could become pregnant must agree to use a reliable form of contraception for at least 28 days before treatment begins and for up to 12 months after receiving the CAR-T cell therapy; men who could father a child must agree to use a barrier contraceptive method from the start of treatment until 12 months after receiving the therapy, and must not donate sperm during the trial

For people with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease affecting many parts of the body):

• People diagnosed with SLE according to recognised international medical classification criteria (confirm with trial site)
• People who test positive for certain antibodies associated with SLE (ANA, anti-dsDNA, or anti-Smith antibodies)
• People whose SLE disease activity score is above a certain level at the start of the study (confirm with trial site)

For people with Systemic Sclerosis (SSc, also known as scleroderma):

• People diagnosed with SSc according to recognised international medical criteria
• People with the diffuse form of SSc, where the disease has been present for 6 years or less

For people with ANCA-Associated Vasculitis (AAV, a type of autoimmune disease affecting blood vessels):

• People diagnosed with a type of AAV — including Microscopic Polyangiitis, Granulomatosis with Polyangiitis, or Eosinophilic Granulomatosis with Polyangiitis — according to recognised international criteria
• People who have tested positive for certain antibodies associated with AAV (MPO-ANCA or PR3-ANCA) either at the start of the study or within the 3 months before

For people with Idiopathic Inflammatory Myopathy (IIM, a group of autoimmune muscle diseases):

• People diagnosed with IIM — including Dermatomyositis, Anti-Synthetase Syndrome, or Immune-Mediated Necrotizing Myopathy — according to recognised international criteria
• People whose disease is currently active, shown by abnormal results in at least 2 out of 6 specific measures of muscle strength, disease activity, and physical function (confirm with trial site)

For people with Sjögren's Syndrome (SS, an autoimmune condition affecting moisture-producing glands):

• People diagnosed with primary Sjögren's Syndrome according to recognised international criteria
• People who test positive for anti-SSA/Ro antibodies either at the start of the study or within the 3 months before
• People whose Sjögren's disease activity score is 5 or higher at the start of the study (confirm with trial site)

Who may not be able to join:

• People with SLE who have had a severe, uncontrolled lupus flare in the 8 weeks before the study starts — including serious complications affecting the kidneys, brain, blood, heart, lungs, liver, or blood vessels — where the treating doctor considers participation unsafe
• People with IIM who have a severe breakdown of muscle tissue, or whose muscle enzyme (CK) levels are extremely high at the start of the study (confirm with trial site)
• People with severe asthma or severe Chronic Obstructive Pulmonary Disease (COPD) — noting that people with mild or moderate asthma or COPD who are on stable treatment may still be considered eligible (confirm with trial site)
• People who have had an active infection requiring antibiotic or antiviral treatment within 2 weeks before a certain stage of treatment, such as pneumonia or tuberculosis
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis under certain conditions (confirm with trial site for details)
• Women who are pregnant or currently breastfeeding
• People with any other condition that the trial doctor believes could affect their safety, their ability to take part, or the reliability of the study results

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