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 between 18 and 69 years old
• You have been officially diagnosed with Systemic Lupus Erythematosus (SLE, a chronic autoimmune disease) using standard medical criteria
• Your lupus is still active despite trying standard treatments such as steroids and hydroxychloroquine, plus at least one other medication (such as mycophenolate, methotrexate, azathioprine, tacrolimus, cyclophosphamide, rituximab, or belimumab)
• Your lupus is active because you were unable to tolerate standard treatments, plus at least one other medication
• Your lupus requires ongoing steroid use to keep it under control
• Your kidneys are working well enough, as measured by a standard formula (confirm with trial site)
• Your heart is pumping adequately, with a heart function score of at least 40% on an ultrasound test
• Your blood oxygen level is at least 92% while breathing normal room air
• Your liver is functioning within acceptable ranges, based on blood test results

Who may not be able to join:

• Your lupus is currently affecting your brain or mental health (active neuropsychiatric lupus)
• You have a serious lupus-related complication involving an overactive immune response in your organs called hemophagocytic lymphohistiocytosis (confirm with trial site)
• You have a medical or mental health condition that might make it hard to follow the study schedule and requirements
• You currently have an active, untreated infection of any kind
• You have a possible fungal infection that has not been treated with the appropriate antifungal medication for at least 2 weeks, or you still have symptoms
• You have active tuberculosis that has not been treated for at least 4 weeks, or you still have symptoms
• You have active or latent (inactive but present) hepatitis B, or active hepatitis C, based on a test done within 8 weeks of joining
• You tested positive for HIV within 8 weeks of joining
• You currently have significant nerve-related side effects or toxicity (above a mild level), unless you have a history of well-controlled seizures or stable neurological problems that have not worsened in the past month
• You have certain inherited conditions affecting your bone marrow, such as Fanconi anemia, Kostmann syndrome, or Shwachman syndrome (people with Down Syndrome are not excluded)
• A bone marrow test has shown signs of a blood cell disorder called myelodysplasia
• You are pregnant or currently breastfeeding, as the treatment may carry risks to a baby
• You are a woman who could become pregnant and are not willing or unable to use highly effective contraception during treatment and for at least 6 months after the treatment (note: periodic methods like calendar tracking or withdrawal are not considered acceptable)
• You are a man who is not willing to use effective contraception and refrain from donating sperm during treatment and for at least 6 months afterward
• You have received a live vaccine in the last two weeks
• It has been fewer than 28 days since you took part in another experimental treatment study
• You are currently taking high-dose steroids or medications that suppress a specific part of your immune system called T cells (you would need to reduce or stop these before joining)
• You have previously received any gene therapy or cell therapy treatment
• You have another serious, uncontrolled health condition — such as unstable heart disease, severe heart failure, uncontrolled HIV, seizure disorder, stroke-related disease, or serious mental illness — that could affect your ability to receive or tolerate the treatment
• You currently have an active cancer, other than certain minor skin cancers or very early-stage cancers that are not likely to interfere with the study (confirm with trial site)

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