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:

• People who are 18 years of age or older, of any gender, at the time of signing the consent form.
• People whose blood cell counts meet certain minimum levels — including white blood cells, a type of white blood cell called centrocytes, and haemoglobin — without having received a specific type of blood-boosting medication in the two weeks before screening (confirm with trial site).
• People whose liver function test results (ALT, AST, and total bilirubin) fall within an acceptable range based on standard reference limits.
• People whose kidneys are working at a sufficient level, measured by a calculation called creatinine clearance of at least 30 mL/min.
• People whose blood clotting measures (INR and PT) fall within an acceptable range based on standard reference limits.
• People with a confirmed diagnosis of rheumatoid arthritis (RA) according to 2010 international classification guidelines, whose disease has remained active after at least 3 months of treatment with one or more standard or biological disease-modifying medications, and who have been on a stable dose of one or more of those medications for a set period before joining.
• People with a confirmed diagnosis of systemic lupus erythematosus (SLE) according to 2019 international guidelines, with at least 6 months of disease history, active disease for at least 2 months despite standard treatment, specific antibody test results, and a disease activity score of 8 or higher during screening.
• People with a confirmed diagnosis of Sjögren's syndrome according to recognised international criteria, with a specific low platelet count condition, a disease activity score of 5 or higher during screening, at least 6 months of disease history, active disease for 2 months despite standard treatment, and more than 6 months of immune-modifying medication use.
• People with a confirmed diagnosis of systemic sclerosis according to 2013 international guidelines, with a positive antinuclear antibody test at screening, clear evidence of lung changes on a specific type of scan (HRCT), and at least 6 months of disease history with active disease for 2 months despite standard treatment.

Who may not be able to join:

• People who have a significant brain or nervous system condition unrelated to their autoimmune disease, such as stroke, epilepsy, dementia, Parkinson's disease, or certain other neurological or psychiatric conditions.
• People with a serious heart condition, such as angina, heart attack, heart failure, or irregular heart rhythm.
• People who have previously had a major organ transplant or a stem cell or bone marrow transplant.
• People who received a vaccination or a B-cell targeted therapy within 4 weeks before screening.
• People with any history of cancer (malignant disease).
• People with end-stage kidney failure.
• People with an active or suspected infection that is not under control, including fungal, bacterial, viral, or other types.
• People with a history of serious allergic reactions to any of the medications or ingredients used in this trial, such as cyclophosphamide, fludarabine, DMSO, or similar substances.
• People who have an active hepatitis B infection, or who test positive for hepatitis C antibodies, HIV antibodies, syphilis, CMV DNA, or EBV DNA.
• Women who are pregnant or breastfeeding, or who plan to become pregnant within 2 years of receiving the trial treatment; also male participants whose partner plans to become pregnant within 2 years of the male participant receiving the trial treatment.
• People with evidence of active tuberculosis infection.
• People who the trial investigator considers unsuitable for any other reason.

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