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 aged 18 to 65 years old (any gender) may be considered.
• People whose blood tests show a protein called CD19 is present on certain immune cells (B cells), confirmed by a laboratory test called flow cytometry.
• People whose bone marrow is functioning well enough, shown by blood counts meeting minimum levels (neutrophils and haemoglobin above set thresholds, without the use of certain boosting medications).
• People whose liver is functioning well enough, shown by liver enzyme and bilirubin levels within acceptable ranges (some allowance is made if the disease itself is causing the elevation).
• People whose kidneys are functioning well enough, with a kidney filtration rate of at least 30 mL/min as calculated by a standard formula (excluding sudden recent declines).
• People whose blood clotting levels are within an acceptable range.
• People who are cardiovascularly stable.
• People who are able to use medically approved contraception or abstain from sexual activity during treatment and for at least 12 months afterwards (applies to people who could become pregnant or whose partners could become pregnant).
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before joining, and must not be breastfeeding.
• People who are willing to take part voluntarily and sign a consent form.

In addition, people must have one of the following specific conditions:

• People diagnosed with systemic lupus erythematosus (SLE) — a condition where the immune system attacks the body — using recognised medical criteria, with a disease activity score of 6 or higher (or significant organ involvement such as kidney disease), whose disease has continued or returned despite at least two immunosuppressive treatments used for at least two months.
• People diagnosed with Sjögren's syndrome — a condition causing dry eyes and mouth among other symptoms — using recognised medical criteria, with a disease activity score of 6 or higher, who test positive for a specific antibody (anti-SSA/Ro), and whose disease has continued or returned despite conventional treatment for more than six months.
• People diagnosed with systemic sclerosis (scleroderma) — a condition causing skin thickening and internal organ involvement — using recognised medical criteria, who test positive for related antibodies, who have either widespread skin thickening or active lung scarring (shown on a specialist scan), and whose disease has either continued or returned after more than six months of conventional treatment, or is showing rapid worsening of skin or lung function (confirm with trial site).
• People diagnosed with inflammatory myopathy — a group of conditions causing muscle inflammation (including dermatomyositis, polymyositis, antisynthetase syndrome, or necrotising myopathy) — using recognised medical criteria, who test positive for specific muscle antibodies, who meet certain measures of muscle weakness or active lung involvement, and whose disease has either continued or returned after more than six months of treatment, or is rapidly worsening.
• People diagnosed with ANCA-associated vasculitis — a condition involving inflammation of small blood vessels — using recognised medical criteria, who test positive for specific related antibodies, who have an active disease severity score of 15 or more (out of 63), and whose disease has continued or returned despite conventional treatment for more than six months.
• People diagnosed with antiphospholipid syndrome — a condition where the immune system increases the risk of blood clots — using recognised medical criteria, who test positive for related antibodies on at least two occasions, and who have had clots return despite standard blood-thinning treatment and prior immunosuppressive therapy; or people with the severe form called catastrophic antiphospholipid syndrome meeting specific criteria (confirm with trial site).
• People diagnosed with rheumatoid arthritis (RA) — a condition causing joint inflammation — using recognised medical criteria, with a diagnosis of at least 3 months, who have not responded well to at least two standard disease-modifying medications and at least one biological treatment, who have at least 6 swollen and 6 tender joints, and who have at least one elevated marker of inflammation in their blood.
• People diagnosed with IgG4-related disease — a condition where certain immune cells cause inflammation and scarring in various organs — using recognised medical criteria, with an active disease score of 2 or higher, and whose disease has either not responded to steroid-based treatment or has returned after a period of improvement.

Who may not be able to join:

• People with a history of severe allergic reactions to medications, or who are generally known to have a highly reactive allergic constitution.
• People who have an existing or suspected infection (fungal, bacterial, viral, or other) that is not controlled or has not been treated.
• People with central nervous system conditions, except where those conditions are caused by the underlying disease being studied (confirm with trial site).
• People whose heart function is not strong enough to tolerate the study treatment.
• People born with a condition causing a lack of antibodies (immunoglobulin deficiency).
• People who have had a cancer diagnosis within the past five years.
• People with end-stage kidney failure.
• People who test positive for active hepatitis B, hepatitis C, HIV, or syphilis, based on specific blood test results (confirm with trial site for details).
• People with a psychiatric condition or severe problems with memory or thinking.
• People who have taken part in another clinical trial within the three months before joining.
• People who have recently taken certain immunosuppressive or biological medications within a set timeframe before joining (confirm exact timeframes with trial site).
• People who are pregnant or planning to become pregnant.
• People who the trial doctors determine have other reasons that make participation unsuitable.

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