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:

General requirements for all participants:

• People who are willing and able to sign a written consent form agreeing to take part
• People aged 18 to 75 years old
• People whose bone marrow is working well enough, shown by blood counts being above certain levels, without having needed a blood transfusion or growth factor injections in the 7 days before screening (confirm with trial site)
• People whose liver is functioning within acceptable ranges, based on blood test results
• People whose blood clotting ability falls within an acceptable range, based on blood test results
• People whose lungs are working adequately, meaning they are not severely short of breath and their blood oxygen level is at least 92% while breathing normal room air
• Women who could become pregnant must have a negative pregnancy test before joining
• Women who could become pregnant, and men whose partners could become pregnant, must use highly effective contraception from the time of signing consent until 6 months after receiving the study treatment

People with anti-GBM disease (a condition where the immune system attacks the kidneys):

• People who have been formally diagnosed with anti-GBM disease and have tested positive for anti-GBM antibodies
• People who have evidence of kidney involvement, confirmed by a kidney biopsy taken within the past year, along with protein and blood detected in their urine

People with Lupus (SLE) or Lupus Nephritis (LN):

• People who have been formally diagnosed with lupus according to recognised international classification standards
• People who have tested positive for certain immune markers in their blood associated with lupus (ANA, anti-dsDNA, or anti-Sm antibodies)
• People whose lupus disease activity score (SLEDAI-2K) is above 6 at the time of screening, indicating active disease

People with ANCA-associated vasculitis (AAV) or related kidney disease (AAGN):

• People who have been formally diagnosed with microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to recognised international classification standards
• People who have tested positive for certain antibodies (MPO-ANCA or PR3-ANCA) either at screening or based on past test results
• For people with vasculitis that has not affected the kidneys, a disease activity score (BVAS version 3) of 3 or higher at screening, indicating the disease is active

People with membranous nephropathy (MN), a kidney condition:

• People who have been diagnosed with primary (idiopathic) membranous nephropathy confirmed by a kidney biopsy taken within the past 2 years
• People whose condition is considered high-risk, meaning they have significant protein in their urine, their kidney function or protein levels have not improved enough with standard blood pressure–related treatment, and certain blood or antibody levels fall outside normal ranges (confirm with trial site for specific thresholds)
• People whose condition has not responded to prior immune-suppressing treatments, meaning protein in their urine remains high despite treatment
• People whose condition returned after previously responding to immune-suppressing treatment

People with systemic sclerosis (SSc), also known as scleroderma:

• People who have been formally diagnosed with systemic sclerosis according to recognised international classification standards
• People who have the subtype known as diffuse cutaneous systemic sclerosis at the time of screening

People with idiopathic inflammatory myopathy (IIM), a group of conditions causing muscle inflammation:

• People who have been formally diagnosed with IIM according to recognised international classification standards, with a probability score of 55% or higher, including the subtypes dermatomyositis, anti-synthetase syndrome, or immune-mediated necrotising myopathy

Who may not be able to join:

People with Lupus (SLE/LN):

• People who have severe active lupus affecting the brain or nervous system, such as psychosis, seizures, or other significant neurological symptoms, as assessed by a specialist during screening
• People whose lupus was caused by a medication or another underlying condition

People with ANCA-associated vasculitis (AAV/AAGN):

• People whose vasculitis was caused by a medication or another underlying condition
• People who have bleeding in the lungs severe enough to require breathing support from a machine at the time of screening

People with anti-GBM disease:

• People who have had no urine output at all for more than 7 days
• People who have been dependent on dialysis for more than 30 days
• People who have ongoing moderate to severe lung bleeding, or whose lung bleeding stopped less than two weeks ago, where that bleeding required breathing assistance, extra oxygen, or a blood transfusion
• People who have heart failure causing significant symptoms (classified as NYHA Class 2 to 4) and who need prescription medication for it, or who have noticeable fluid-related swelling due to a heart condition

People with membranous nephropathy (MN):

• People whose membranous nephropathy is caused by another condition or disease (known as secondary membranous nephropathy)

People with idiopathic inflammatory myopathy (IIM):

• People who have severe muscle breakdown (rhabdomyolysis) or a very high level of a muscle enzyme called CK (creatine kinase) in their blood at screening (120 times or more above the normal upper limit)

People with systemic sclerosis (SSc):

• People who have had a serious kidney crisis related to scleroderma within the past year
• People who have had fluid build-up around the heart (cardiac tamponade) within the past 6 months
• People who have an active infection of finger ulcers within the past 3 months
• People who have tissue death (gangrene) affecting their fingers at the time of screening

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