Phase 1 Lupus 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 5 years old or older
• You have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) using specific 2019 medical guidelines, and your disease is still moderately to severely active despite taking high-dose steroids, hydroxychloroquine, and at least 2 other treatments for 3 or more months — or you cannot tolerate the standard treatments
• Your lupus activity score (called SLEDAI-2K) is 8 points or higher, meaning your disease is considered active (confirm with trial site)
• Your heart is working well enough (pumping at least 55% efficiency) with no major heart rhythm problems on an ECG
• Your kidneys are functioning at an adequate level (confirm with trial site)
• Your liver enzyme and bilirubin levels are within an acceptable range (confirm with trial site)
• Your lungs are reasonably healthy, with blood oxygen levels of 92% or above
• You are able to have a blood collection procedure with no medical reasons preventing it
• If you are a woman who could become pregnant, you have a negative pregnancy test and agree to use effective contraception for at least one year after treatment
• You (or your legal guardian, if applicable) understand the trial, agree to take part, and are willing to sign a consent form

Who may not be able to join:

• You have previously received CAR-T cell therapy
• You have lupus affecting your central nervous system (brain or spinal cord) that has needed treatment within the last 60 days
• You currently have active tuberculosis
• You have a history of a heart condition present from birth, a heart attack within the last 6 months, serious heart rhythm problems, significant fluid around the heart, serious heart muscle inflammation, or you need medication to keep your blood pressure stable
• You have another condition that requires long-term use of steroids or strong immune-suppressing medicines
• You have an infection that cannot be controlled, or an active infection requiring treatment within the week before joining the trial
• You have previously had an organ transplant or a stem cell transplant, or have experienced a significant graft-versus-host disease reaction within the past 2 weeks
• You have active Hepatitis B, Hepatitis C, HIV, syphilis, or an active cytomegalovirus (CMV) infection detected in your blood
• You have received a live vaccine within the 4 weeks before joining the trial
• You have a positive blood pregnancy test
• You have had, or currently have, any type of cancer
• You have taken part in another clinical trial within the 3 months before enrolling
• The trial doctors have any other concerns that make you unsuitable for the study (confirm with trial site)

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