Early Phase 1 Lupus Trial, Recruiting

Written by an AI model from the 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 18 years of age or older.
• If your kidneys are affected, they must still be working at a minimum level (your doctor will check this with a kidney function test).
• Your blood test results taken within 3 days before a key procedure must meet certain minimum levels for white blood cells, infection-fighting cells, platelets, and red blood cells — your doctor will review these (confirm with trial site).
• Your kidney filtering function, as measured by a specific formula, must meet a minimum level (confirm with trial site).
• Your liver-related blood test results must be within acceptable ranges (confirm with trial site).
• Your blood clotting test results must be within acceptable ranges (confirm with trial site).
• If you are able to have children, you must agree to use effective birth control from when you sign the consent form until 1 year after receiving the study treatment, and pregnancy tests must come back negative before treatment.
• You (or your guardian) must be willing to sign a consent form showing you understand and agree to take part in the study.
• If you have Lupus Nephritis (LN): You must have been diagnosed with lupus according to specific medical guidelines, have had a kidney biopsy within the last 6 months confirming an active and serious form of lupus kidney disease (type III, IV, V, or combinations), and have already tried standard treatments that either didn't work or stopped working.
• If you have Lupus Nephritis (LN): Certain antibody blood tests during screening must come back positive.
• If you have Lupus Nephritis (LN): Your lupus disease activity score must reach a certain minimum level during screening (confirm with trial site).
• If you have IgG4-Related Disease (IgG4-RD): You must have been diagnosed with IgG4-RD according to specific 2019 medical guidelines.
• If you have IgG4-RD: Your condition must be recurring or not responding to treatment.
• If you have IgG4-RD: Your disease activity must be above a certain level as measured by a specific scoring tool (confirm with trial site).
• If you have IgG4-RD: Your condition must match a specific pattern of the disease involving certain glands or multiple body systems (confirm with trial site).

Who may not be able to join:

• You are currently pregnant or breastfeeding.
• You have been diagnosed with a cancerous tumour within the past 5 years (some exceptions may apply for certain fully treated skin, cervical, prostate, or thyroid cancers — confirm with trial site).
• You received certain medicines that reduce B-cells (a type of immune cell) within the 6 months before the treatment infusion, unless your B-cells have recovered.
• You received immune-suppressing medicines within 3 days before the treatment infusion, or steroid medicines above a low dose within 3 days before the infusion.
• You received a live vaccine or a certain type of live therapy within 2 weeks before screening.
• You have an active or ongoing hepatitis B infection (unless the virus level is very low), hepatitis C, HIV, or syphilis.
• You currently have an active infection that requires intravenous antibiotics or a hospital stay.
• You have significant heart problems, such as very high levels of a heart stress marker in your blood, severe heart failure, or a heart attack, unstable chest pain, or a heart procedure (such as a stent or bypass surgery) within the past 6 months.
• You have a known allergy or serious reaction to any ingredient in the study treatment or related medicines used in the study (including fludarabine, cyclophosphamide, or albumin).
• You have any other condition that the study doctor believes makes it unsafe or unsuitable for you to take part.

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