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 who are 18 years of age or older, of any gender, at the time of signing the consent form.
• People whose blood test results show adequate bone marrow function, including sufficient white blood cell levels, a type of immune cell called neutrophils, and haemoglobin (confirm with trial site for exact values).
• People whose liver function tests (ALT, AST, and bilirubin) are within an acceptable range as determined by the trial site.
• People whose kidneys are working well enough, based on a measure called creatinine clearance being at or above a certain level (confirm with trial site).
• People whose blood clotting tests (INR and PT) are within an acceptable range.
• People with a confirmed diagnosis of rheumatoid arthritis (RA) according to recognised international criteria, whose disease has remained active after at least 3 months of treatment with one or more standard or biological disease-modifying drugs, and who are currently on a stable dose of one or more of those medications.
• People with a confirmed diagnosis of systemic lupus erythematosus (SLE) according to recognised international criteria, with at least 6 months of disease history, active disease after standard treatment, and specific blood markers and disease activity scores meeting set thresholds.
• People with a confirmed diagnosis of Sjögren's syndrome according to recognised international criteria, with a specific complication involving low platelet counts, a disease activity score of 5 or more, at least 6 months of disease history, active disease after standard treatment, and at least 6 months of immune-modifying treatment.
• People with a confirmed diagnosis of systemic sclerosis according to recognised international criteria, with a positive antinuclear antibody blood test, evidence of lung changes on a specific type of scan (HRCT), and at least 6 months of disease history with active disease after standard treatment.

Who may not be able to join:

• People who have a significant brain or nervous system condition not caused by their underlying disease, such as stroke, epilepsy, dementia, Parkinson's disease, or a serious mental health disorder.
• People with significant heart conditions, such as angina, heart attack, heart failure, or irregular heart rhythms.
• People who have previously had a major organ transplant, or a bone marrow or stem cell transplant.
• People who received a vaccination or a therapy targeting B-cells (a type of immune cell) within 4 weeks before the screening visit.
• People with any history of cancer (malignant disease).
• People with end-stage kidney failure.
• People with an active infection that is not under control, whether caused by fungi, bacteria, viruses, or other organisms.
• People with a known severe allergy to any of the drugs used in the study, including cyclophosphamide, fludarabine, or components used in handling the trial drug.
• People with an active hepatitis B infection, or who test positive for hepatitis C antibodies, HIV, syphilis, or certain viral markers (CMV DNA or EBV DNA).
• Women who are pregnant or breastfeeding, or who plan to become pregnant within 2 years after receiving the trial drug; also, male participants whose partners plan to become pregnant within 2 years of the male participant receiving the trial drug.
• People with evidence of an active tuberculosis infection.
• People whom the trial investigators assess as unsuitable for other medical reasons.

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