Phase 1 Vasculitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who are able to understand what the study involves and are willing to follow the study procedures and sign a consent form.
• People who are able to use two forms of contraception together throughout the study (examples include hormonal birth control, an IUD, condoms with spermicide, or surgical sterilisation).
• People whose oral steroid dose has been reduced to less than 20 mg per day of prednisone (or an equivalent medication) at least one week before starting treatment.
• People whose lung function test results meet specific minimum levels — a carbon monoxide diffusing capacity (DLCO) above 60% and a breathing airflow measure (FEV1) above 70% (confirm with trial site).
• People whose heart pumping function (left ventricular ejection fraction) is at least 45% as shown on an echocardiogram (heart ultrasound).
• People whose blood test results show that their blood cell counts, kidney function, and liver function all meet minimum levels set by the trial (confirm with trial site for specific numbers relevant to each condition).

For Rheumatoid Arthritis (RA) specifically, people who:

• Have a confirmed RA diagnosis meeting recognised classification criteria.
• Have previously tried at least two biologic or targeted medicines for at least 12 weeks and did not benefit enough, or could not tolerate at least two of these treatments.
• Currently have at least 6 swollen joints and 6 tender joints.

For Pemphigus Vulgaris (PV) specifically, people who:

• Have a confirmed diagnosis of pemphigus vulgaris with active skin or mucous membrane sores.
• Test positive for certain skin-protein antibodies (anti-Dsg1 or anti-Dsg3).
• Have a disease activity score above 10% on a standard scale used for this condition.
• Have already tried standard treatments (such as methotrexate, azathioprine, mycophenolate mofetil, corticosteroids, or intravenous immunoglobulin) for at least 12 weeks without enough improvement.

For Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) specifically, people who:

• Have a confirmed clinical diagnosis of GPA or MPA.
• Test positive for certain immune markers in the blood (c-ANCA, PR3-ANCA, or MPO-ANCA).
• Have a disease activity score on a recognised scale (BVASv3) that meets minimum threshold levels (confirm with trial site).
• Have already tried standard immunosuppressive treatments or rituximab for at least 12 weeks without enough improvement.

For Systemic Lupus Erythematosus (SLE) specifically, people who:

• Have a confirmed SLE diagnosis meeting recognised 2019 classification criteria.
• Have a disease activity score (SLEDAI-2K) of at least 8 at the screening visit (certain symptoms such as hair loss, mouth ulcers, and fever are not counted in this score).
• Test positive for anti-double-stranded DNA antibodies.
• Have already tried and not responded well to at least two standard treatments (such as antimalarials, immunosuppressants, or biologics) for at least 12 weeks each.
• Are taking any current background medications (such as hydroxychloroquine or immunosuppressants) at a stable dose for the minimum period required by the trial before starting study treatment (confirm with trial site for specific timeframes).

Who may not be able to join:

• People who have received cyclophosphamide (a type of chemotherapy/immunosuppressant) within the past 3 months.
• People whose blood test results at screening fall outside the ranges the trial requires, unless the doctor confirms this does not affect safety or study goals.
• People with a known allergy or medical reason to avoid any of the study drugs, including cyclophosphamide, fludarabine, rituximab, or AB-101.
• People who have had a severe allergic reaction to contrast dyes, human or animal proteins, monoclonal antibody treatments, or DMSO (a chemical solvent).
• People who have received any B-cell targeting treatment (such as rituximab or similar medicines) within the 3 months before the planned start of treatment.
• People who have previously received any cell therapy using genetically modified immune cells (such as CAR-T cell therapy).
• People who have received immunoglobulin replacement therapy or plasmapheresis (a blood-filtering treatment) within the past 6 months.
• People who have had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell or bone marrow transplant, or who are scheduled to receive one.
• People with a current or past cancer diagnosis, with limited exceptions for certain early-stage, non-invasive, or fully resolved cancers (confirm with trial site).
• People with any history of a cancer affecting B cells (a type of immune cell), even if fully treated.
• People with significant heart conditions, including recent unstable chest pain or heart attack (within the past 6 months), severe heart failure, recent inflammation around the heart, or certain abnormal heart rhythm readings at screening.
• People who still have unresolved side effects from previous treatments that have not improved to a low level (Grade 1 or below).
• People with significant unstable or uncontrolled health conditions unrelated to their autoimmune disease, which in the doctor's opinion could affect the study or their safety.
• People with a planned surgical procedure, or other medical conditions or practical factors that the doctor considers would make participation unsuitable.
• People who have signs or symptoms of an active illness or infection, or who have received any vaccination (live or non-live) within 6 weeks of the first study day.
• People with a current or recent history (within the past year) of drug or alcohol misuse or dependence.
• People who test positive for HIV during the screening period.
• People who are currently pregnant or breastfeeding, or who plan to breastfeed within 6 months of the last dose of AB-101.
• People with any other medical, psychological, family, or social circumstances that the doctor believes would interfere with their ability to safely take part in the study.
• People whose health has significantly worsened in the 2 weeks before the first study day.
• People with a known significant lung disease, or a history of chronic lung conditions (such as COPD or asthma) that result in lung function below the trial's required levels.
• People whose autoimmune disease has affected their lungs in a way that may reduce lung function.
• People with a history of smoking of 5 pack-years or more (confirm with trial site for how this is calculated), or who currently use any tobacco products.
• People with a history of low antibody levels (low IgG) or who have received intravenous immunoglobulin (IVIG) treatment within the 3 months before screening.

For Rheumatoid Arthritis specifically, people who:

• Have another rheumatologic autoimmune disease in addition to RA (except secondary Sjögren's syndrome).
• Have serious body-wide complications from RA, such as blood vessel inflammation or lung scarring.
• Have another type of arthritis, or who were diagnosed with arthritis before the age of 16, or who have active fibromyalgia that could interfere with RA assessments.

For Pemphigus Vulgaris specifically, people who:

• Have any condition — including active flares or new lesions — that the doctor believes would interfere with full participation in the study.

For GPA/MPA specifically, people who:

• Have another autoimmune disease affecting multiple body systems.
• Have ongoing significant infections requiring active management.

For SLE specifically, people who:

• Have lupus that was caused by a medication (drug-induced lupus).
• Have a history of severe anti-phospholipid syndrome (a condition involving blood clotting and immune system problems).

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