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:

• People who have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) according to recognised 2019 classification guidelines, with a diagnosis history of at least 6 months
• People aged between 18 and 60 years old (inclusive) at the time of signing the consent form, with no restriction on gender
• People who have not had a widespread active infection (such as infectious pneumonia or tuberculosis) in the 2 weeks before screening
• People who have been taking a combination of steroid medications and immune-suppressing drugs, and/or biological therapies, for at least 3 months before screening, at a stable dose for at least 2 weeks, and whose disease is still considered active
• People whose lupus disease activity score (SLEDAI-2K) is 7 or higher during screening, or who have significant organ involvement such as severe immune-related low platelet counts or active lupus kidney disease (confirm with trial site)
• People with active involvement of organs such as the kidneys, heart, lungs, joints, blood system, or blood vessels during screening (skin and mouth/mucous membrane involvement alone does not meet this requirement)
• People whose kidneys, bone marrow, liver, blood clotting, lungs, and heart are functioning at the minimum levels required by the trial (confirm specific values with trial site)
• Women who could become pregnant must agree to use effective contraception starting at least 28 days before a specific stage of the treatment and continuing until 1 year after receiving the study treatment, and must not donate eggs within 1 year of receiving the study treatment
• Male participants who could father a child must agree to use effective barrier contraception from a specific stage of the treatment until 1 year after receiving it, and must not donate semen or sperm at any point during the study
• Women who could become pregnant must have a negative pregnancy blood test within 48 hours before screening and before a specific treatment stage

Who may not be able to join:

• People who, within the 2 months before screening, needed dialysis or required high-dose steroid treatment (prednisone 100 mg/day or equivalent for 14 or more days) due to severe lupus kidney disease
• People who have had plasma exchange, plasma separation, or dialysis within 30 days before screening, or who experienced a lupus crisis within that same period
• People with a history of significant bleeding (Grade 2 or higher) or who require ongoing blood-thinning medication, within 30 days before screening
• People who have had certain serious heart conditions within 30 days before screening, including severe heart failure, heart attack, unstable chest pain, uncontrolled heart rhythm problems, or other significant heart disease
• People who have had nervous system symptoms caused by lupus before screening, such as severe headaches, seizures, memory or thinking problems, or vision problems
• People with a history of other brain or nervous system conditions before screening, including stroke, encephalitis, epilepsy, Parkinson's disease, dementia, psychiatric disorders, or related conditions
• People with an active widespread infection, including active tuberculosis, within 2 weeks before screening
• People who have previously received CAR-T cell therapy or other genetically modified T cell treatments, or who have had a major organ transplant (heart, lung, kidney, or liver) or a stem cell or bone marrow transplant
• People who have had a serious allergic reaction to certain medications used in or alongside this trial, including tocilizumab or components of the study treatment (confirm specific medications with trial site)
• People who have used B-cell targeting drugs such as rituximab within the 6 months before screening
• People who have used certain other biological therapies (such as taceptil or belimumab) within the 12 weeks before screening
• People using steroid medication at a dose of 10 mg/day or more of prednisone (or equivalent) within 2 weeks before the study treatment infusion (low-dose replacement therapy, topical, and inhaled steroids are permitted)
• People who have taken certain immune-suppressing medications that affect T cells within 2 weeks before the study treatment infusion
• People who have taken JAK inhibitor medications within 2 weeks before the study treatment infusion
• People who have received any vaccine (live, inactivated, or RNA-based) within one month before screening
• People diagnosed with a cancer within the 2 years before signing the consent form, with some exceptions for certain treated, early-stage, or non-spreading cancers (confirm with trial site)
• People who have had major surgery within 4 weeks before signing the consent form, or who have major surgery planned during the study, if the study doctor considers this to carry unacceptable risk
• People found during screening to have HIV, syphilis, active hepatitis B, or active hepatitis C infection
• People currently participating in another clinical trial, or still within a certain period after finishing another trial's medication
• People with serious uncontrolled long-term health conditions that the study doctor believes may increase risk
• People with a history of suicidal thoughts within the previous 6 months, or suicidal behaviour within the previous 12 months, where the study doctor judges there to be significant risk
• Women who are pregnant or breastfeeding
• People who, in the study doctor's assessment, are unlikely or unable to follow the study requirements, or are otherwise not suitable to participate

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