Phase 3 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 6 and 18 years old (including those who are exactly 6 or 18)
• You have been diagnosed with Systemic Lupus Erythematosus (SLE) based on recognised 2019 international guidelines
• You have been diagnosed with an active, serious form of lupus affecting the kidneys (called lupus nephritis, Class III or IV), confirmed by a kidney biopsy taken within the last 6 months
• Your lupus disease activity score is at a certain level of severity (SLEDAI-2000 score of 8 or higher) (confirm with trial site)
• Your lupus nephritis has not responded well to treatment — meaning you have tried two or more immune-suppressing medications for more than 6 months without the disease going into remission, or it came back after remission, and you still have protein in your urine
• A blood test has shown that a certain type of immune cell called CD19 B cells is present in your blood
• You have suitable veins and no medical reason preventing collection of your blood cells
• You and your parent or guardian are willing to give written consent and take part voluntarily
• Your blood cell counts meet certain minimum levels (for example, your white blood cells, infection-fighting cells, and haemoglobin are above set thresholds) (confirm with trial site)
• Your liver is functioning within acceptable limits based on blood tests (confirm with trial site)
• Your kidneys are still functioning at a certain minimum level, as measured by a calculation called eGFR (at least 30 ml/min/1.73m²)
• Your blood clotting results are within acceptable limits (confirm with trial site)
• Your heart is stable
• A specific lupus-related antibody called ANA is present at a level of 1:80 or higher in your blood
• Your general physical ability is rated between 0 and 2 on a standard scale (meaning you are able to carry out everyday activities, possibly with some limitations) (confirm with trial site)

Who may not be able to join:

• You have previously had a kidney transplant
• You have a history of serious allergic reactions to medications
• You currently have an active infection (fungal, bacterial, viral, or other) that is not under control or needs treatment
• You have serious problems with your heart, liver, lungs, or blood clotting
• You were born with a condition that means your body cannot produce enough antibodies (congenital immunoglobulin deficiency)
• You have active Hepatitis B, active Hepatitis C, HIV, or syphilis
• You have been diagnosed with cancer at any point in the last five years
• You have a serious disease of the brain or nervous system, a serious mental illness, or significant problems with thinking or memory
• You have taken part in another clinical trial within the past 3 months
• You have previously received a type of treatment called CAR-T cell therapy
• The trial doctors decide there is another reason that makes participation unsuitable for you

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