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 willing to give their informed consent, understand what the study involves, and are able to complete all trial procedures
• People aged 18 to 70 years, of any gender
• People who have a sufficient level of a specific type of immune cell (CD19-positive B cells) in their blood at the time of screening, as measured by a laboratory test
• People who previously received treatments targeting B cells, and whose B cell counts have since returned to normal or pre-treatment levels
• People with Sjögren's disease whose blood counts (white blood cells, red blood cells, and platelets) meet minimum required levels within 7 days before a preparatory chemotherapy step
• People whose liver, kidney, lung, and heart function meet the minimum required levels at screening (confirm specific thresholds with trial site)
• People with certain kidney function levels below the standard threshold may still be considered if the treating doctor determines the benefits outweigh the risks and full consent is given (confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test at screening; women who have had surgical sterilisation or natural menopause for at least 2 years are considered not at risk of pregnancy
• People who are able to use highly effective contraception throughout the study and for 1 year after the last treatment, and who agree not to donate eggs or sperm for 1 year after the last treatment

For Rheumatoid Arthritis (RA) specifically, people may also need to meet these criteria:

• A confirmed diagnosis of moderate to severe active rheumatoid arthritis for at least 6 months, meeting recognised international classification standards
• At least 6 swollen joints and at least 6 tender joints at the time of screening
• Blood inflammation markers (CRP or ESR) above specified levels at screening
• A history of trying at least 2 different advanced (biological or targeted) arthritis medicines after standard medicines did not work well enough, with ongoing difficulty managing symptoms despite treatment (confirm full definition with trial site)
• At least one sign of active or progressing disease, such as moderate or higher disease activity scores, inability to reduce steroid dose to a low level, worsening joint damage on imaging, or reduced quality of life despite treatment

For Dermatomyositis (DM) specifically, people may also need to meet these criteria:

• A confirmed diagnosis of Dermatomyositis for at least 24 weeks before signing consent, meeting recognised international criteria
• A history of not responding well enough to steroids combined or used in sequence with at least two immune-suppressing medicines, with steroid treatment lasting at least 3 months, plus at least one additional sign of severe or ongoing disease activity (confirm full definition with trial site)
• People with a related condition called anti-synthetase syndrome with certain antibodies present may also be eligible
• People with a related muscle condition (immune-mediated necrotising myopathy) with certain antibodies present may also be eligible

For Systemic Lupus Erythematosus (SLE) specifically, people may also need to meet these criteria:

• A confirmed SLE diagnosis in adults for at least 12 weeks before signing consent, meeting recognised international criteria
• Specific blood test markers (such as antinuclear antibodies or anti-DNA antibodies) above required levels at screening
• Disease activity scores above required levels at both screening and a later baseline visit, showing involvement in one or more organ systems
• Not having responded well enough to standard treatments including steroids, antimalarials, immune-suppressing medicines, and at least one biological medicine used for at least 3 months
• People who received certain blood cell growth-supporting medicines or blood transfusions must wait a specified period before screening assessments (confirm timing with trial site)

For Systemic Sclerosis (SSc) specifically, people may also need to meet these criteria:

• A confirmed SSc diagnosis meeting recognised international criteria, with the disease having been present for no more than 60 months
• Positive blood test results for specific autoantibodies related to SSc
• A skin involvement score of 15 or more out of 51 on a standard assessment scale
• Not having responded well enough to more than 3 months of treatment with steroids and/or certain immune-suppressing medicines, with significant ongoing disease affecting the skin or internal organs; or, in cases of rapidly progressing disease, enrolment may be considered if the treating doctor determines benefits outweigh risks and full consent is obtained

Who may not be able to join:

• People with a history of cancer, unless it was a specific type of skin cancer or cervical pre-cancer that was fully treated and removed at least 5 years ago with no recurrence
• People with severe lung disease, including a high grade of pulmonary hypertension or a need for oxygen support or breathing machines at screening
• People with a known allergy or serious reaction to the study treatment components or to medicines used as part of the treatment process (including fludarabine, cyclophosphamide, or tocilizumab)
• People with a serious active viral, bacterial, or uncontrolled fungal infection at the time of screening or baseline
• People with significant heart failure classified at a moderate to severe level by standard heart function criteria
• People with certain serious heart conditions, including a heart attack in the past 6 months, severe abnormal heart rhythms, significant fluid around the heart, serious heart muscle inflammation, or unstable vital signs requiring blood pressure-supporting medicines
• People with an active infection requiring intravenous antibiotic or antifungal treatment at the time of screening or baseline
• People with certain active hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus infections detected by blood tests
• People with a history of serious herpes infections affecting the brain or eyes, or signs of an active herpes or chickenpox/shingles infection within 12 weeks before screening
• People with active tuberculosis, a history of active tuberculosis, or who do not return a negative tuberculosis screening test result
• People with a history of epilepsy or other active conditions affecting the brain or nervous system
• People with inherited or acquired immune deficiency conditions
• People with other significant medical conditions affecting the heart, hormones, blood, liver, immune system, kidneys, lungs, nerves, skin, or mental health that the treating doctor considers may interfere with the study treatment
• People who have had an organ transplant or stem cell transplant within 3 months before screening, or who have had a significant transplant rejection reaction within 2 weeks before screening
• People who have received a live vaccine within 4 weeks before screening
• People who have recently received certain treatments, including B-cell depleting therapies, specific biological medicines, JAK inhibitors, or other relevant medicines, within specified time periods before the study starts (confirm exact timeframes with trial site)
• People who are currently participating in another clinical trial involving an investigational medicine or device within the past 3 months
• People who, in the treating doctor's judgement, have any condition that may increase their risk or affect the reliability of trial results

For Rheumatoid Arthritis (RA) specifically:

• People whose RA has caused the most severe level of physical functional limitation (ACR functional class Grade 4)

For Dermatomyositis (DM) specifically:

• People whose muscle condition appears to be caused by an underlying cancer diagnosed within the past 2 years, or who are considered at high risk of having an underlying cancer
• People with certain overlapping conditions, such as other connective tissue diseases (except where overlapping with Sjögren's syndrome), inclusion body myositis, polymyositis, or drug-caused muscle disease
• People with other severe musculoskeletal conditions unrelated to DM that would make it difficult for doctors to accurately assess disease activity

For Systemic Lupus Erythematosus (SLE) specifically:

• People with a specific type of lupus kidney disease (Class V lupus nephritis, unless also combined with Class III or IV), active kidney inflammation requiring medicines not permitted in the trial, or a need for dialysis

For Systemic Sclerosis (SSc) specifically:

• People who also have another rheumatic autoimmune disease such as rheumatoid arthritis, lupus, mixed connective tissue disease, polymyositis, or dermatomyositis (note: fibromyalgia, secondary Sjögren's syndrome, and scleroderma-related muscle involvement are not excluded)
• People with skin conditions unrelated to SSc that would make it difficult for doctors to accurately assess SSc disease activity
• People who have had a serious kidney crisis related to SSc within the past 2 years

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