Early 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.
• People who have been diagnosed with systemic lupus erythematosus (an autoimmune condition where the immune system attacks the body) according to recognised 2019 international classification standards.
• People who have had a kidney biopsy within the last 6 months confirming a specific type of lupus-related kidney inflammation (classified as active type III or IV, with or without type V, under international kidney disease guidelines).
• People whose lupus has not responded to standard treatments for more than 6 months, or whose disease has become active again after a period of improvement — this includes people who have tried steroid medications and at least one other immune-suppressing drug or biological therapy.
• People with a lupus disease activity score (SLEDAI-2000) of 8 or higher, indicating moderately to severely active disease.
• People whose kidney inflammation is confirmed as active by specialist scoring tools, and who have a certain level of protein in their urine (confirm with trial site for exact values).
• People whose blood test (using a method called flow cytometry) shows certain markers on their B cells (a type of immune cell) — specifically CD19 or BCMA.
• People whose bone marrow, liver, and kidney function meet minimum levels as measured by blood tests (confirm with trial site for exact values).
• People with a general physical fitness rating (called ECOG score) of 0 or 1, meaning they are fully active or have only minor limitations in daily activities.
• People who are willing and able to use reliable contraception during the study and for at least 6 months after treatment ends; women who could become pregnant must have a negative pregnancy test within 7 days before joining and must not be breastfeeding.
• People who are willing to sign a consent form, attend follow-up visits, and take part fully in the study.

Who may not be able to join:

• People with a history of serious drug allergies or a strong tendency toward allergic reactions.
• People who have an active infection (bacterial, viral, fungal, or other) that is not controlled or that requires treatment.
• People with nervous system conditions related to autoimmune or other diseases, such as epilepsy, psychosis, stroke, encephalitis, or inflammation of blood vessels in the brain.
• People with poor heart function that does not meet the study's requirements.
• People who were born with a condition affecting their immune system's ability to produce antibodies (congenital immunoglobulin deficiency).
• People who have had a cancer diagnosis within the past five years.
• People with end-stage kidney failure (where the kidneys have permanently stopped working).
• People who test positive for hepatitis B or C, or HIV, under specific conditions as determined by blood tests (confirm with trial site for exact details).
• People with a psychiatric disorder or significant problems with memory and thinking.
• People who have taken part in another clinical trial within the 3 months before joining this study.
• People who have recently taken immune-suppressing medications or biological therapies within a specific timeframe before the study (confirm with trial site for exact timing).
• Women who are pregnant or planning to become pregnant.
• People the study doctor considers unsuitable for other reasons.

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