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:

For people with Systemic Lupus Erythematosus (SLE) — a disease where the immune system attacks the body:

• You have been diagnosed with SLE based on specific medical guidelines (2019 ACR/EULAR criteria)
• Certain specific antibodies related to SLE were found in your blood during screening
• Your current treatments (steroids and immune-suppressing medicines) have not worked well enough, or you cannot tolerate them
• Your SLE is currently active at the time of screening

For people with Inflammatory Myopathy (IIM) — a condition causing muscle inflammation:

• You have been diagnosed with IIM based on specific medical guidelines (2017 ACR/EULAR criteria)
• Your IIM is severe and has not responded to previous treatments
• Steroids and immune-suppressing medicines have not worked well enough for you
• Your disease is currently active

For people with Systemic Sclerosis (SSc) — a disease that causes hardening of the skin and can affect organs:

• You have been diagnosed with SSc based on specific medical guidelines (2013 ACR/EULAR criteria)
• Your previous treatments have not worked well enough, or you cannot tolerate them
• Your SSc is getting worse and affects your skin and/or lungs

For people with Rheumatoid Arthritis (RA) — a condition causing joint inflammation:

• Your RA has been difficult to treat
• You have been diagnosed with RA based on specific medical guidelines (2010 ACR/EULAR criteria)
• Your RA is currently active at screening and at the start of the trial
• Standard treatments have not worked well enough, or you cannot tolerate them

Who may not be able to join:

For all participants:

• You have another systemic autoimmune disease (a condition where the immune system attacks multiple parts of the body)
• You are pregnant or currently breastfeeding
• You have active Hepatitis B, Hepatitis C, or HIV
• You have a history of cancer
• You have an infection that is active or not well controlled
• You have had certain heart or blood vessel problems in the 6 months before screening (confirm with trial site)
• You have previously received CAR-T cell therapy (a type of immune cell treatment)
• You have significant lung problems
• Your organs (such as kidneys or liver) are not functioning well enough (confirm with trial site)
• You have an active and serious condition affecting your brain or nervous system

Additionally, for people with SLE:

• Your lupus was caused by a medication, or you have another autoimmune disease alongside SLE

Additionally, for people with IIM:

• You have a different type of muscle disease that is not IIM
• You have severe, lasting muscle damage

Additionally, for people with SSc:

• You have high blood pressure in the arteries of your lungs caused by SSc that requires ongoing treatment to control
• Your SSc is getting worse very rapidly, or you have a history of serious kidney disease related to SSc

Additionally, for people with RA:

• You have another autoimmune disease alongside your RA

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