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 to understand the trial and are willing to sign a consent form, including agreeing to how their data will be used
• Adults who are 18 years of age or older and under 65 years of age at the time of signing consent
• Male participants who are not surgically sterile must agree to use two forms of contraception during the trial and for 12 months after receiving the study treatment
• Female participants who could become pregnant must have a negative pregnancy test at the start of the trial and must agree to use a highly effective form of contraception from the time of signing consent and for 12 months after receiving the study treatment
• People who are able to attend all required study visits and follow the trial's requirements
• People who have received two doses of a COVID-19 vaccine, or have had COVID-19 within the last 6 months (confirm with trial site)
• For people with Systemic Lupus Erythematosus (SLE — a condition where the immune system attacks the body's own tissues): those who meet the internationally recognised 2019 diagnostic criteria for SLE, have certain specific immune markers in their blood, have active disease affecting one or more body systems at a significant level, and have not responded well enough to steroid treatment and at least two other treatments such as hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, or rituximab
• For people with Systemic Sclerosis (SSc — also called scleroderma, a condition causing hardening of the skin and internal organs): those who meet the 2013 diagnostic criteria for SSc, have the diffuse form of the condition with specific immune markers, show signs of fast disease progression including disease duration of 5 years or less, specific skin score measurements, elevated inflammation markers in the blood, and worsening skin involvement, and have not responded well enough to steroids and at least two other treatments such as mycophenolate mofetil, azathioprine, nintedanib, methotrexate, or rituximab
• For people with Dermatomyositis or Polymyositis (DM/PM — conditions causing muscle inflammation and weakness): those who meet the 2017 diagnostic criteria for probable or definite DM or PM, have measurable muscle weakness along with at least two additional signs of disease activity, have at least one specific muscle-related immune marker in their blood, and have not responded well enough to steroids and at least two other treatments such as mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, or intravenous immunoglobulins
• For people with ANCA-Associated Vasculitis (AAV — a condition causing inflammation of blood vessels): those who meet the 2022 diagnostic criteria for MPA, GPA, or EGPA (specific types of vasculitis), have certain immune markers (ANCA antibodies) in their blood, show specific signs of active disease affecting the kidneys or other systems, and have not responded well enough to at least one treatment such as steroids, cyclophosphamide, or a B-cell targeting therapy

Who may not be able to join:

• People for whom the treating doctor judges that a less intensive or already-approved treatment would be appropriate
• People with low levels of certain blood cells (white blood cells, lymphocytes, or red blood cells) or very low levels of a specific type of immune cell (CD3+ T cells)
• People with other significant and uncontrolled medical conditions that could affect their safety or make it hard to interpret the trial results
• People with serious heart conditions, including a recent heart attack, recent heart procedure, unstable chest pain, significant heart rhythm problems, heart failure, or reduced heart pumping function
• People with any other condition or abnormal test result that the trial team considers would put them at unacceptable risk or make the results difficult to interpret
• People with significantly reduced kidney function (as measured by a specific kidney test result below a set threshold)
• People with advanced scarring lung disease shown on a chest scan, combined with significantly reduced lung capacity on breathing tests
• People with a serious active infection, including HIV (even if the virus is currently undetectable), active hepatitis B or C, active COVID-19, or active tuberculosis; people with latent (inactive) tuberculosis may be eligible if they have already started treatment for it according to local guidelines before joining the trial
• People who are pregnant or breastfeeding
• People with a known allergy or sensitivity to any of the drugs or other substances that will be used during the trial, including those used during a preparatory treatment phase
• People who have had a cancer diagnosis in the last 5 years before screening; people who previously had a completely removed early-stage cancer (carcinoma in situ) that required only surgery may still be considered eligible (confirm with trial site)
• People who have previously received CAR T cell therapy
• People whose current treatment schedule is not compatible with the washout periods required before and during the trial (confirm with trial site)
• People who are currently taking part in another clinical trial or receiving another experimental treatment
• People who have received an experimental treatment that may have affected T or B cells (types of immune cells) as part of a clinical trial within the past 2 years
• People who need to receive a live vaccine during the trial period or within 14 days before a blood collection procedure
• People under 18 years of age or people who are not able to understand the purpose and consequences of the trial and give informed consent
• People who have had a problem with alcohol or substance misuse in the 6 months before the trial, if the investigator considers this could increase risks or affect the results
• People who have a close personal or family relationship with the trial sponsor or the doctors running the trial
• For people with SLE specifically: people who have a history of severe involvement of the brain or nervous system, including conditions such as brain blood vessel inflammation, stroke-related events, seizures, or severe lupus-related headaches
• People who have been diagnosed with more than one overlapping connective tissue disease (such as SLE together with Sjögren's Syndrome or Rheumatoid Arthritis), or who have been diagnosed with Mixed Connective Tissue Disease

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