Phase 1 Sjogren's Syndrome 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 between 18 and 65 years old
• You are generally able to carry out daily activities (your overall health and activity level meets a certain standard — confirm with trial site)
• Your major organs (such as kidneys, liver, and heart) are working well enough to safely participate
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting and agree to use a highly effective form of birth control from the start of a preparatory treatment through to 2 years after receiving the study treatment
• If you have Systemic Sclerosis (SSc/scleroderma): You meet the official 2013 diagnostic criteria for SSc; your skin thickening score is above a certain level; at least one internal organ (beyond the skin) is affected; and your condition has not responded to, or has come back after, at least one immune-suppressing or biologic medication
• If you have Primary Sjögren's Syndrome (pSS): You meet the official 2016 diagnostic criteria for pSS; you have a specific antibody (anti-Ro/anti-SSA) in your blood; your disease activity score reaches a certain level; and your condition has not responded to, or has come back after, at least one immune-suppressing or biologic medication

Who may not be able to join:

• You have an active infection that is not under control
• You have chronic Hepatitis B and are unable or unwilling to take antiviral medication to prevent it from reactivating, or your Hepatitis B virus is currently detectable in your blood
• You have Hepatitis C that has not been fully treated, or the virus is still detectable in your blood
• You have tested positive for HIV
• You have tested positive for syphilis
• You have active tuberculosis (TB), or a latent (inactive) TB infection that has not been properly treated
• You have had a serious infection requiring a hospital stay or intravenous antibiotics in the last 3 months, or have taken antibiotic/antiviral tablets or capsules in the last month
• You have a specific heart rhythm condition called Long QT Syndrome, or a certain abnormality was found on your heart tracing (ECG) at screening (confirm with trial site)
• You have poorly controlled high blood pressure, unstable chest pain, significant heart failure, signs of reduced blood flow to the heart, or had a heart procedure or heart attack within the last 6 months; or you have an uncontrolled irregular heartbeat, poorly controlled diabetes or other hormone-related conditions, severe long-term lung disease, or another serious health condition that could make it unsafe to take part
• You have previously had an organ transplant
• You are currently pregnant or breastfeeding
• You have taken another experimental or investigational drug within the past 4 weeks (or within a timeframe based on that drug's specific properties — confirm with trial site)
• You have received a biologic medication within the past 10 weeks, or had a stem cell transplant within the past 6 months
• You have previously been treated with CAR-T cell therapy
• You have received a live or weakened (attenuated) vaccine within 4 weeks before the study treatment begins
• You have another autoimmune or inflammatory condition (such as rheumatoid arthritis, gout, or active fibromyalgia) that might affect how results are measured
• If you have SSc specifically: You are considered at risk of a serious kidney complication related to scleroderma; you have a specific stomach blood vessel condition linked to SSc; or you have severe gut involvement causing problems absorbing nutrients
• If you have pSS specifically: You also have a liver condition called primary biliary cholangitis

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