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 3 to 65 years, of any sex.
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE) according to the 2019 international classification standards set by EULAR and ACR.
• People whose blood tests show certain specific markers of SLE activity (a positive ANA test at a certain level, and/or a positive anti-dsDNA antibody test).
• People whose SLE has not responded well to standard treatments — specifically, those who still need high doses of steroids to keep the disease under control, or whose disease has come back after seeming to improve, despite having tried standard medications for at least 6 months.
• People with a specific kidney complication of SLE (called lupus nephritis) that has been confirmed by a kidney biopsy taken within the last 6 months, and whose kidneys have not responded to standard treatment after 3 to 6 months.
• People whose B cells (a type of immune cell) still show a marker called CD19+, and who have been off immunosuppressive medications for more than one week.
• People whose blood counts show a lymphocyte (a type of white blood cell) level above 1 × 10⁹/L, and who have no reason that would prevent blood cell collection.
• People with no history of severe allergic reactions.
• People who are well enough to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 to 2) (confirm with trial site).
• People who are expected to live for at least 90 days.
• People (or their legal guardian, where applicable) who are able to understand and sign a consent form agreeing to participate.

Who may not be able to join:

• People with reduced consciousness, raised pressure in the brain, brain damage from stroke or inflammation, or other brain conditions requiring active treatment.
• People with significant heart problems, including a weakened heart pump (ejection fraction below 45%), certain abnormal heart rhythms, a heart condition affecting daily activity, unstable chest pain, or a heart attack within the past 6 months.
• People with serious breathing problems, including low oxygen levels at rest, high pressure in the lungs, the need for ongoing oxygen support, or lung diseases unrelated to SLE (such as pneumonia or scarring of the lungs).
• People who have another cancer alongside their SLE.
• People with a serious blood clotting disorder called disseminated intravascular coagulation (DIC).
• People with an active, uncontrolled infection (bacterial, viral, fungal, or parasitic), except for fungal nail infections.
• People with diabetes that remains poorly controlled despite at least 3 months of treatment, or who have serious diabetes-related complications.
• People with serious mental illness, alcohol or drug dependence, dementia, or any condition that would affect their ability to participate safely or give informed consent.
• People with active brain lesions visible on an MRI scan.
• People who have had an organ transplant (other than a stem cell transplant).
• People who are pregnant or breastfeeding.
• People who test positive for hepatitis, HIV/AIDS, or syphilis.
• People from whom the specialised blood cells needed to manufacture the CAR T cell treatment cannot be collected or stored.
• People whose kidneys are functioning below a certain level (eGFR below 30 ml/min/1.73m²), indicating significant kidney impairment.
• People who are unable to stop immunosuppressive medications for at least 7 days, or whose condition gets worse when they try to stop them, and where the trial doctor assesses the risk as too high.
• People with an active skin condition that could interfere with assessing SLE, such as psoriasis, dermatomyositis, systemic sclerosis, or certain other skin conditions not caused by SLE.

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