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:

• Blood cell counts, liver function, kidney function, heart function, and lung function must meet minimum levels set by the trial (with some exceptions allowed depending on the condition being treated — confirm with trial site)
• Blood oxygen levels must be at or above 92%, and a heart scan must show the heart is pumping adequately with no major structural problems
• Women who could become pregnant must use an accepted method of contraception or abstain from sexual activity during the treatment period and for at least 12 months after treatment ends
• Participants (and a parent or guardian if the participant is a child) must be willing and able to provide written consent after being fully informed about the study

For people with Systemic Lupus Erythematosus (SLE — a chronic autoimmune condition):

• People aged 5 years and older
• Diagnosis of SLE confirmed using recognised international classification standards
• Disease that remains active or severe despite trying standard treatments, including steroids and at least two other immune-suppressing medicines, for at least 3 months; or disease that has not responded to treatment; or a disease activity score meeting specific thresholds set by the trial; or people who cannot tolerate standard treatments (confirm details with trial site)
• No episode of a serious complication called macrophage activation syndrome in the month before screening
• Certain serious nervous system symptoms related to lupus occurring within 60 days before screening — such as seizures, psychosis, or stroke-like events — may be a requirement for some participants (confirm with trial site)

For people with Multi-Drug Resistant Steroid-Resistant Nephrotic Syndrome (a kidney condition that hasn't responded to standard treatment):

• People aged 3 years and older
• Diagnosis confirmed according to 2021 international kidney disease guidelines
• Disease that has not responded to at least two standard kidney medicines with different mechanisms (including at least one calcineurin inhibitor), or that has come back after a period of improvement; or people who cannot tolerate standard treatments (confirm with trial site)
• Kidney tissue sample (biopsy) showing one of two specific types of kidney disease: minimal change disease or focal segmental glomerulosclerosis

For people with IgA Nephropathy (a kidney condition caused by immune protein deposits):

• People aged 5 years and older
• Diagnosis confirmed by kidney biopsy
• Treatment with certain blood pressure medicines (ACE inhibitors or ARBs) for at least 3 months, plus at least one of the following: combination treatment with steroids and an immune-suppressing medicine for 3 or more months with ongoing significant protein in the urine; a rapid decline in kidney function of more than 50% within 3 months; or inability to tolerate standard treatment (confirm with trial site)
• No other identified cause for the kidney disease, and blood pressure must be controlled

For people with Systemic Sclerosis (Scleroderma — a condition causing skin and organ hardening):

• People aged 5 years and older
• Diagnosis confirmed using 2013 international classification criteria
• Specific blood markers (antibodies) related to scleroderma must be present
• Skin involvement score of 15 or more out of 51 on a standard medical scale
• Disease that has not improved after at least 3 months of treatment with steroids plus at least one immune-modifying medicine; or rapidly worsening disease unresponsive to standard treatment; or inability to tolerate standard treatment (confirm with trial site)

For people with Refractory or Relapsed ANCA-Associated Vasculitis (a condition involving inflammation of blood vessels):

• People aged 5 years and older
• Diagnosis confirmed using recognised international criteria, covering two specific types of vasculitis (microscopic polyangiitis or granulomatosis with polyangiitis)
• Disease that has not responded adequately to at least 3 months of standard treatment; or disease that has returned or worsened after achieving remission; or severe vasculitis with inadequate response to standard care (confirm with trial site)
• A disease activity score of 10 or above on the appropriate scale for the participant's age group, indicating active vasculitis

Who may not be able to join:

• People with a known severe allergic reaction or intolerance to cyclophosphamide or tocilizumab, which are medicines used in this trial
• People with severe heart failure (Grade III or IV on a standard medical scale)
• People with a history of a heart condition present from birth, or a heart attack within the past 6 months; or serious abnormal heart rhythms; or significant fluid around the heart; or serious heart muscle inflammation; or unstable vital signs requiring blood pressure medicines
• People with an active, uncontrolled infection at the time of screening, or an infection requiring systemic treatment
• People with active tuberculosis of the lungs at the time of screening
• People with active hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus infection detected through blood tests
• People with a history of severe herpes infections (such as herpes affecting the brain or eyes), or signs of an active herpes or chickenpox/shingles infection within 12 weeks before screening
• People with active disease affecting the central nervous system (brain and spinal cord) at the time of screening (confirm with trial site, as this criterion may interact with lupus-related nervous system involvement)
• People with a current or previous diagnosis of cancer or other malignant disease
• People with a secondary or inherited condition causing immune system deficiency
• People with a serious medical condition affecting the heart, hormones, blood, liver, immune system, metabolism, lungs, nervous system, skin, mental health, or kidneys — other than lupus — that would prevent safe participation
• People who have received a solid organ transplant or bone marrow/stem cell transplant within 3 months before screening, or who have had a significant graft-versus-host disease reaction within 2 weeks before screening
• People who have received a live vaccine within 4 weeks before screening
• People with a positive blood pregnancy test
• People who have participated in another clinical trial and received any study treatment within 3 months before enrolling
• People with laboratory test results that the trial doctors consider clinically significant enough to prevent safe participation
• People in any situation that the trial doctors judge could increase risk or affect the reliability of trial results

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