Phase 2 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 12 to 29 years old at the time of joining the trial.
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE) according to recognised international classification guidelines.
• People whose blood tests show a positive ANA result above 1:80 and/or a positive double-stranded DNA (dsDNA) result.
• People whose SLE is still active despite previous treatments — for those with kidney involvement (lupus nephritis), this means having a specific type of kidney inflammation confirmed by biopsy within the past 12 months, plus ongoing significant protein in the urine; for those without kidney involvement, this means having a high disease activity score or being unable to reduce steroid doses to a low level due to ongoing active disease.
• People who have already tried at least 3 months of standard treatments, including at least one immunosuppressive medication and at least one additional therapy such as a B-cell targeting biologic, a calcineurin inhibitor, or another immunosuppressive medication used for SLE.
• People whose organs are functioning at an adequate level, including the kidneys (with kidney function above a certain threshold and not currently on dialysis), liver (with liver enzyme and bilirubin levels within acceptable ranges), heart (with adequate pumping function and no severe lung blood pressure issues), and lungs (with acceptable breathing capacity and oxygen levels).
• People who are able to become pregnant must agree to use acceptable methods of contraception during the trial.

Who may not be able to join:

• People who have an active infection that is not currently being treated.
• People who have HIV.
• People who have active Hepatitis B (a negative Hepatitis B surface antigen test result is required).
• People who have active Hepatitis C.
• People who have severe neurological or psychiatric symptoms related to lupus, such as stroke, seizures, psychosis, or related conditions.
• People who have a known genetic (monogenic) form of lupus.
• People who have previously had an autologous or allogeneic stem cell transplant.
• People who have previously had a kidney transplant.
• People who have a history of a seizure disorder.
• People who are currently taking anti-epileptic (anti-seizure) medication.
• People who have recently participated in another clinical trial involving an experimental drug, within a timeframe based on how long that drug stays in the body (confirm with trial site).
• People who are unwilling or unable to stop their immunosuppressive medications at the time of the trial's cell therapy infusion.
• People with other serious health conditions that, in the opinion of the trial doctors, could make it unsafe to participate.
• People who are currently pregnant — a negative pregnancy test is required for anyone who could potentially become pregnant.
• People who are currently breastfeeding and wish to continue doing so.
• People who are unwilling to consent to long-term follow-up after the trial.

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