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:

• People aged 5 years or older
• People diagnosed with Systemic Lupus Erythematosus (SLE) according to recognised 2019 international classification standards, whose disease remains moderately to severely active despite at least 3 months of high-dose steroids, hydroxychloroquine, and at least 2 other standard treatments from an approved list — or who have been unable to tolerate standard treatments
• People with a disease activity score (SLEDAI-2K) of 8 or higher, indicating significant disease activity
• People whose heart is functioning well enough (heart pumping capacity of 55% or more, with no major abnormalities on a heart tracing test)
• People whose kidneys are functioning at a sufficient level (eGFR of 30 mL/min/1.73m² or above)
• People whose liver test results are within an acceptable range (specific enzyme and bilirubin levels must not be too high)
• People whose lungs are functioning adequately, with no serious lung damage and an oxygen level of 92% or above
• People who have not previously received CAR-T cell therapy, or people who have received CAR-T therapy targeting a protein called CD19 but whose disease came back or did not respond well (as assessed by the study doctor)
• People who are medically suitable for the blood cell collection process required before treatment
• Female participants of childbearing age who have a negative pregnancy test before joining, and who agree to use effective contraception for the first year after receiving the treatment
• People (or their guardians, where applicable) who agree to take part and sign a consent form showing they understand the study's purpose and procedures

Who may not be able to join:

• People who have lupus affecting the brain or nervous system that has required medical intervention within the past 60 days
• People who have received kidney dialysis or similar kidney replacement treatment within the past 3 months, or who the study doctor believes are likely to need high-dose steroids or strong immune-suppressing drugs for serious kidney disease within 3 months of joining
• People with a history of a heart condition present from birth, a heart attack within the past 6 months, serious irregular heart rhythms, significant fluid around the heart, serious heart muscle inflammation, or unstable vital signs requiring blood pressure-raising medication
• People who have another long-term condition that requires ongoing use of steroids or strong immune-suppressing medications
• People with an active infection that cannot be controlled, or who have needed treatment for an infection in the week before screening
• People who have had an organ transplant or bone marrow/stem cell transplant, or who have experienced a significant transplant rejection reaction (Grade 2 or higher) within the past 2 weeks
• People who test positive for active Hepatitis B, Hepatitis C, HIV, syphilis, or cytomegalovirus (CMV) infections at levels above normal reference ranges
• People who have received a live vaccine within the 4 weeks before screening
• People who test positive on a blood pregnancy test
• People who have had, or currently have, any form of cancer
• People who have taken part in another clinical trial within the past month, or anyone the study doctor considers unsuitable for other reasons

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