Early Phase 1 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:

• You are willing and able to give your consent to take part (or a legal representative can do so on your behalf)
• You are between 18 and 70 years old (inclusive), of any gender
• You have been diagnosed with systemic lupus erythematosus (SLE) that has not responded well to standard treatments, AND you also have either lupus affecting the kidneys (confirmed by biopsy and showing significant protein in the urine) or a very low platelet count (below 50×10⁹/L on at least two tests, with a platelet count still above 10×10⁹/L)
• You have been diagnosed with a condition called ANCA-associated vasculitis (a type of blood vessel inflammation affecting major organs such as the kidneys or lungs) that has not responded to, or has come back after, standard treatments including cyclophosphamide or rituximab, and you have tested positive for anti-PR3 or anti-MPO antibodies (now or in the past)
• You have a type of muscle and skin disease called MDA5-positive dermatomyositis that has not responded well to steroid treatment and/or at least one other immunosuppressive medication
• If you are a woman who could become pregnant, you must have a negative blood pregnancy test within 7 days before starting the preparatory treatment for the trial
• All participants who are capable of having children must agree to use effective contraception throughout the study and for at least 1 year after receiving the treatment
• Your liver is functioning adequately, based on specific blood test results being within acceptable ranges
• Your kidneys are functioning adequately (kidney patients with lupus nephritis may have some flexibility on this — confirm with trial site)
• Your blood oxygen level is above 91% without extra oxygen support
• Your lymphocyte count (a type of white blood cell) is above a minimum level set by the trial

Who may not be able to join:

• You have severe, active lupus affecting your brain or nervous system (such as seizures, psychosis, or a stroke) that required treatment within the past 60 days
• You are currently on dialysis
• You are pregnant or breastfeeding
• You have an infection that is not under control (such as blood poisoning, a serious fungal infection, or an uncontrolled lung infection)
• You have tested positive for Hepatitis B, Hepatitis C, HIV, or syphilis
• You have had major surgery within 4 weeks before the screening visit, and the trial doctors consider this a concern
• You have significant heart problems, including poor heart pumping function, severe heart failure, certain serious heart rhythm problems, a recent heart attack or heart surgery within the past 6 months, or other heart conditions the doctors consider unsuitable (confirm with trial site for specifics)
• You have received a live vaccine within 6 weeks before the screening visit
• You have taken part in another clinical trial or received an experimental treatment within 3 months before the cell infusion
• You have a history of epilepsy or another active condition affecting the brain or nervous system
• You have a known allergy to any ingredients used in this treatment
• You have previously been treated with CAR-T cell therapy
• The trial doctors believe there is another reason that makes it unsuitable for you to take part (confirm with trial site)

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