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 18 or older, of any gender, who are willing to sign a consent form
• People whose bone marrow is producing enough blood cells — specifically, white blood cell counts, infection-fighting cells (neutrophils), and red blood cells (hemoglobin) must all meet minimum levels
• People whose liver is functioning well enough, based on standard blood test results
• People whose kidneys are filtering blood at an adequate rate
• People whose blood clotting levels fall within an acceptable range

For people with Rheumatoid Arthritis, the following also apply:

• People who have been diagnosed with rheumatoid arthritis using recognised medical criteria (2010 ACR/EULAR)
• People whose arthritis has remained active or poorly controlled after at least 3 months on a standard treatment plan, or who have been unable to reduce steroid (prednisone) doses below a certain level, and who have 3 or more swollen or tender joints
• People who have been on one or two standard disease-modifying arthritis medicines (such as methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide) at stable doses for a minimum period before joining

For people with Lupus (SLE), the following also apply:

• People who have been diagnosed with lupus using recognised medical criteria (2019 EULAR/ACR)
• People who have had lupus for at least 6 months and whose disease has remained active for 2 or more months despite standard treatment
• People whose lupus activity score (SLEDAI-2000) is 8 or higher during the screening period
• People whose organ involvement has been assessed as reaching a certain level of severity using a standard lupus scoring tool (BILAG-2004)
• People who test positive for at least one lupus-related antibody (antinuclear antibody, anti-dsDNA, or anti-Sm)

For people with Sjögren's Syndrome ("dry syndrome"), the following also apply:

• People who have been diagnosed with Sjögren's syndrome using recognised medical criteria (2002 or 2016 classification criteria)
• People who have a related low platelet count (below 30 × 10⁹/L), a condition referred to in the criteria as pSS-TP
• People who have had Sjögren's syndrome for at least 6 months and whose disease has remained active for at least 2 months despite conventional treatment, including high-dose steroids, cyclophosphamide, and other immune-modifying medicines used for more than 6 months

For people with Systemic Sclerosis, the following also apply:

• People who have been diagnosed with systemic sclerosis using recognised medical criteria (2013 ACR classification)
• People who test positive for antinuclear antibodies at screening
• People who have clear evidence of disease progression in the lungs, seen on a specialised type of chest scan (HRCT)
• People who have had systemic sclerosis for at least 6 months and whose disease has remained active for at least 2 months despite conventional treatment, including steroids and cyclophosphamide for more than 6 months

Who may not be able to join:

• People who have a significant brain or nervous system condition not caused by their autoimmune disease, such as stroke, epilepsy, dementia, Parkinson's disease, severe head injury, or related conditions
• People who have serious heart conditions, such as angina, heart attack, heart failure, or significant irregular heartbeat
• People who have had a major organ transplant, or a stem cell or bone marrow transplant
• People who have received a vaccine or B-cell targeted therapy within 4 weeks before screening
• People who have any history of cancer (malignant disease)
• People with end-stage kidney failure
• People who have an active or suspected uncontrolled infection of any kind (fungal, bacterial, viral, or other)
• People who have had a severe allergic reaction to any medicines used in the trial, including cyclophosphamide, fludarabine, or DMSO
• People who test positive for certain infections, including active hepatitis B (HBV), hepatitis C (HCV), HIV, syphilis, cytomegalovirus (CMV), or Epstein-Barr virus (EBV)
• People who are pregnant, breastfeeding, or planning to become pregnant within 2 years after receiving the trial treatment; also, male participants whose partners plan to become pregnant within 2 years of the treatment
• People with evidence of active tuberculosis
• People whom the trial investigators assess as unsuitable for the trial for any other reason

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