Phase 1 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 between 18 and 75 years old at the time of screening
• People who have been formally diagnosed with systemic lupus erythematosus (SLE/lupus), meeting a specific number of recognised diagnostic criteria under established international classification systems
• People who have had a positive result on a specific lupus-related blood test (ANA at a certain level, or anti-dsDNA antibody) within the 6 months before screening
• People whose kidneys are functioning at or above a certain level, based on a blood test measuring kidney filtering ability (confirm with trial site)
• People who have been taking at least one non-steroid lupus medication (such as an immunosuppressant or antimalarial drug) for at least 12 weeks before screening
• People whose lupus disease activity scores at least 6 on a standard medical scoring tool called SLEDAI-2K at the time of screening (confirm with trial site)
• People who are willing and able to give written consent to participate
• People who are able and willing to attend all required study visits and follow the study requirements

Who may not be able to join:

• People who have a condition other than lupus that required steroid treatment (by mouth or injection) for more than 2 weeks total in the 12 weeks before screening
• People who have been on dialysis within the 12 months before screening, or who are expected to need dialysis or a kidney transplant within 6 months of joining
• People who have been taking a higher-than-specified dose of steroid medication (prednisone above 0.5 mg/kg/day or an equivalent steroid) in the 4 weeks before screening
• People who have started, stopped, or changed a non-steroid immunosuppressant or antimalarial medication within 12 weeks before screening
• People who have received an experimental treatment within a specified timeframe before the study start date (either 90 days or 5 times the drug's half-life, whichever is longer)
• People who have received a commercially available biologic medicine within the same washout timeframe before the study start date
• People who have received a prior mesenchymal stem cell (MSC) therapy within 52 weeks before the study start date
• People who have previously received certain cell-based therapies, such as CAR-T cells or regulatory T-cell (Treg) therapies (prior MSC therapy is an exception to this)
• People who have had major surgery within 90 days before the study start date, or who have major surgery planned during the study period
• People who have a confirmed active infection with hepatitis B, hepatitis C, HIV, or tuberculosis
• People who have any active infection that has not been fully treated or resolved before the study start date
• People with a history of cancer, except for certain fully treated minor skin cancers or cervical carcinoma in situ
• People who are currently pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the trial
• People who are not willing to use a medically acceptable form of contraception for the full duration of the trial
• People with other health conditions that the trial doctor considers would make participation unsafe or unsuitable
• People with other medical conditions that the trial doctor believes could affect the reliability of the study results

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