Rheumatoid Arthritis 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:

• Adults aged 18 or older, of any gender, who are able to sign a consent form in person (or have a guardian sign on their behalf) before any screening begins.
• People diagnosed with rheumatoid arthritis (RA) according to recognised 2010 diagnostic guidelines, whose condition has not responded well to treatment — specifically, those who have tried and not responded to standard disease-modifying medications, have also tried at least two different biological or targeted medications, and still have significant disease activity, ongoing joint swelling or pain in three or more joints, or require steroid doses that cannot be reduced below a certain level.
• People who have been on one or two standard disease-modifying medications at a stable dose for a set minimum period before joining (for example, methotrexate for at least 12 weeks, or hydroxychloroquine, sulfasalazine, or leflunomide for at least 4 weeks, within specified dose ranges).
• People with no signs of active or latent (hidden/dormant) tuberculosis.
• People whose kidneys, liver, and lungs are functioning at an adequate level, as defined by specific test results (confirm with trial site).
• People whose heart is pumping adequately, with a heart function measurement (left ventricular ejection fraction) of at least 45%, confirmed by a heart scan.
• People of childbearing potential (both female and male) who agree to use a highly effective form of contraception for at least 12 months after receiving the trial treatment, and until specific blood tests confirm the treatment is no longer detectable in the body.

Who may not be able to join:

• People who have or have had a cancer (malignant tumour) diagnosis.
• People with current or past neurological or brain conditions, such as seizures, stroke, dementia, cerebellar disease, or any autoimmune condition affecting the brain or nervous system.
• People who have previously had a bone marrow or stem cell transplant from a donor.
• People who have received chemotherapy (other than the pre-treatment chemotherapy that is part of this trial) within 2 weeks before the planned infusion.
• People who have taken part in another clinical trial using an experimental drug within 30 days before signing the consent form.
• People with active hepatitis B or hepatitis C infection, as determined by specific blood test results.
• People who test positive for HIV antibodies or syphilis antibodies.
• People with a serious, uncontrolled bacterial, viral, or fungal infection that is life-threatening (for example, a positive blood culture within 72 hours before the infusion).
• People who have lost or donated more than 400 mL of blood, or received a blood transfusion, within the 2 months before screening.
• People with a known allergy to any drugs or ingredients used in this trial, including fludarabine, cyclophosphamide, or DMSO.
• People who have used certain immune-suppressing or cell-destroying medications within specific timeframes before or during the study (confirm with trial site for exact timeframes).
• People who are pregnant (confirmed by a blood test) or currently breastfeeding.
• People who have another systemic inflammatory condition in addition to RA — such as lupus, Crohn's disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, gout, or systemic vasculitis, among others (secondary Sjögren's syndrome is an exception and may be permitted — confirm with trial site).
• People who have had unstable chest pain (angina) or a heart attack in the 6 months before signing the consent form.
• People whom the trial investigators consider unsuitable for participation for other medical or practical reasons, such as concerns about ability to follow the trial requirements.

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