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:

• Adults aged 18 or older (in Spain) or people aged 12 to 65 (in the UK) at the time of joining the study
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) based on recognised international classification guidelines
• People whose blood tests show certain specific markers (autoantibodies) associated with lupus, at particular levels
• People whose lupus is severe and has not responded to previous treatments

Who may not be able to join:

• People who have received a specific type of antibody treatment called anti-CD20 therapy within the 2 months before the cell collection procedure
• People who have previously received anti-CD19 therapy, T cell therapy, or any gene therapy (such as CAR T cell therapy)
• People who have received a live or weakened vaccine within 2 months before the cell collection procedure
• People with recurring or currently active, severe, or unstable lupus affecting the brain or mental health within the past 2 years
• People whose lupus was caused by a medication rather than occurring on its own
• People having a severe lupus flare-up during the screening period that needs immediate treatment
• People who have serious, likely permanent organ damage from lupus (such as complete kidney failure) where the treatment is unlikely to help, in the opinion of the doctor
• People diagnosed with another autoimmune condition alongside lupus (such as rheumatoid arthritis, scleroderma, or similar conditions)
• People who have had, within the 3 months before screening, significant brain or nervous system problems such as epilepsy, stroke, paralysis, or blood clots in the legs or lungs
• People with a history of serious brain injury, dementia, Parkinson's disease, uncontrolled mental illness, or psychosis
• People with significant, uncontrolled heart disease unrelated to lupus, or who have had a serious heart event within the past 12 months
• People with an active or uncontrolled infection (including COVID-19) currently requiring treatment
• People with active or latent hepatitis B, or active hepatitis C
• People who test positive for HIV, HTLV-1, HTLV-2, or syphilis at screening
• People with a history of cancer, unless they have been cancer-free for at least 24 months (some skin cancers or early-stage breast cancer on hormonal therapy may be exceptions — confirm with trial site)
• People who have had a heart, lung, kidney, liver, or stem cell transplant
• People who are pregnant or breastfeeding
• People whose heart is not pumping blood effectively enough, as measured by a heart scan (confirm with trial site)
• People whose blood oxygen level is below 90% without oxygen support
• People who have very low or absent levels of B cells (a type of immune cell) in their blood

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