Engineered immune cells take aim at Hard-to-Treat lupus

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 to 50 years, inclusive. * Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 ACR/EULAR classification criteria. * Active disease at screening, defined as SLEDAI-2K ≥4 and Physician Global Assessment (PGA) ≥0.5. * Inadequate response, intolerance, or contraindication to corticosteroids and at least two of the following therapies: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, belimumab, rituximab, or tacrolimus. * Adequate organ function, including: * Hepatic function: AST and ALT ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN (participants with documented Gilbert syndrome are eligible). * Hematologic function: neutrophils ≥1,000/mm³; hemoglobin ≥8 g/dL without transfusion within 14 days; lymphocytes ≥500/mm³; platelets ≥20,000/mm³ without transfusion within 14 days. * Renal function: estimated creatinine clearance ≥30 mL/min (CKD-EPI). * Cardiac function: left ventricular ejection fraction ≥40%. * Pulmonary function: oxygen saturation ≥92% on room air. * Women of childbearing potential must agree to use highly effective contraception during study participation and for 12 months after CAR-T cell infusion. * Male participants must agree to use barrier contraception during study participation and for 12 months after CAR-T cell infusion. * Ability to understand and provide written informed consent. Exclusion Criteria: * Severe pulmonary hypertension (estimated pulmonary artery systolic pressure \>50 mmHg). * Requirement for systemic anticoagulation at screening. * Clinically significant cardiovascular disease, including NYHA Class III/IV heart failure, myocardial infarction, unstable arrhythmias, or unstable angina within the previous 6 months. * Active neurological disease (stroke, epilepsy, or neurodegenerative disorders) within the previous 12 months. * History of malignancy within 2 years prior to screening, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or stage I uterine cancer. * Previous or suspected hemophagocytic lymphohistiocytosis/macrophage activation syndrome. * Active or uncontrolled bacterial, viral, fungal, or other infection. * Active hepatitis B infection or detectable HBV DNA. * Active hepatitis C infection or detectable HCV RNA. * Human immunodeficiency virus (HIV) infection. * Pregnancy, breastfeeding, or plans to become pregnant during the study or within 12 months after CAR-T cell infusion. * Major surgery within 4 weeks prior to screening. * Administration of a live attenuated vaccine within 4 weeks prior to screening. * Prior allogeneic or autologous hematopoietic stem cell transplantation or prior solid organ transplantation. * Inability or unwillingness to comply with study procedures and follow-up requirements. * Any medical condition that, in the investigator's judgment, could compromise participant safety or interfere with study assessments.