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:

• You are 18 years old or older
• You have been diagnosed with one of the following conditions: Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome, Systemic Scleroderma, Dermatomyositis (with a specific positive antibody test result), or a type of blood vessel inflammation called ANCA-associated vasculitis (including GPA, MPA, or EGPA) — diagnosed using specific medical standards
• Your disease is considered active enough to meet specific scoring thresholds set for each condition (confirm with trial site for the exact score required for your condition)
• You are generally well enough to carry out light activity or normal daily tasks (rated 0 or 1 on a standard health performance scale)
• Your blood counts meet minimum levels — for example, haemoglobin of at least 60g/L and platelets of at least 30×10⁹/L
• Your heart is pumping well enough, with no major abnormalities on a heart tracing (ECG)
• Your kidneys are working at a sufficient level (eGFR of at least 30 mL/min/1.73m²)
• Your liver test results are within acceptable ranges
• Your lungs are functioning above minimum required levels on breathing tests
• You are able to have blood taken or cells collected without major complications
• If you could become pregnant, you have a negative pregnancy test and agree to use effective contraception during the trial and for one year after receiving the treatment
• You (or your guardian) fully understand the trial and are willing to sign a consent form agreeing to take part

Who may not be able to join:

• You have previously received a type of treatment called CAR T cell therapy
• You have serious heart, liver, lung, blood, hormonal, or other organ problems where the risks of joining the trial are considered greater than the possible benefits (as judged by the medical team)
• You have an active or uncontrolled infection that needs treatment throughout the body within one week before assessment
• You have previously had a stem cell transplant or organ transplant (except cornea or hair transplants), or have had a significant transplant rejection reaction within two weeks before assessment
• You have active Hepatitis B, Hepatitis C, HIV, syphilis, or an active cytomegalovirus (CMV) infection based on blood tests
• You have received a live vaccine within four weeks before assessment
• You have a positive pregnancy test
• You have or have had a cancer diagnosis, with some exceptions such as certain fully treated skin cancers, early-stage cervical cancer, or certain prostate or breast cancers that have been treated with surgery (confirm with trial site)
• You have taken part in another clinical trial within the three months before assessment
• The medical team considers participation to be unsuitable for you for any other reason

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