Experimental CAR-T therapy takes aim at Hard-to-Treat lupus kidney disease

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

Inclusion Criteria: * Age 19 years or older, voluntarily provides written informed consent. * Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria. * Positive antinuclear antibody (ANA) at screening (titer ≥1:80). * Diagnosis of lupus nephritis Class III or IV (with or without concurrent Class V), confirmed by kidney biopsy within 1 year prior to screening based on ISN/RPS 2018 criteria. * Inadequate response to, or intolerance of, at least two or more standard therapies for 6 months or longer (cyclophosphamide, mycophenolate mofetil, azathioprine, tacrolimus, rituximab, belimumab). * Proteinuria at screening with urine protein-to-creatinine ratio (UPCR) \>1.5. * Adequate laboratory values at screening: Hemoglobin \>8.0 g/dL; ANC \>1,000/μL; Platelets ≥50,000/μL; Total bilirubin ≤2.0 × ULN; AST and ALT ≤3 × ULN; eGFR ≥30 mL/min/1.73 m². * Hemodynamically stable, no pericardial effusion, and LVEF ≥50% by echocardiogram at screening. * FEV1/FVC ≥70% at screening. * Willing and able to comply with study visits, procedures, and requirements. * Women of childbearing potential and men must agree to use effective contraception for at least 1 year after CRC01 infusion until PCR testing confirms clearance of CRC01. Exclusion Criteria: * Current or anticipated requirement for renal dialysis during the study. * History of kidney transplantation or planned transplantation during the study. * History of severe CNS lupus or currently active severe CNS lupus. * Prior CAR-T cell therapy. * History of malignancy except for: basal or squamous cell carcinoma of skin treated and disease-free ≥3 years; in-situ carcinoma of cervix or breast treated and disease-free ≥3 years; superficial bladder cancer treated and disease-free ≥3 years; completely resected primary malignancy in complete remission ≥5 years. * Unstable angina and/or myocardial infarction within 1 year prior to screening. * Congestive heart failure of NYHA Class III or IV within 1 year prior to screening. * Thromboembolism, pulmonary embolism, or clinically significant bleeding diathesis within 6 months prior to screening. * Hypoxemia, clinically significant pleural effusion, or abnormal ECG findings within 6 months prior to screening. * Stroke (ischemic or hemorrhagic) within 6 months prior to screening. * Positive HBsAg; positive anti-HCV (eligible if HCV RNA negative); known HIV infection; or active neurological autoimmune/inflammatory diseases (e.g., Guillain-Barré syndrome, ALS). * Recurrent or symptomatic ventricular tachycardia, or atrial fibrillation with rapid ventricular response despite therapy within 3 months prior to screening. * Severe or uncontrolled active infection requiring systemic therapy at screening. * Rapidly progressive disease or otherwise unsuitable for study participation, per investigator judgment. * Pregnant or breastfeeding women. * Known hypersensitivity to investigational product components. * Participation in another investigational study within 4 weeks prior to screening. * Receipt of systemic corticosteroids at therapeutic doses within 7 days prior to leukapheresis (≤7.5 mg/day prednisone equivalent is permitted). * Receipt of immunosuppressive agents within 7 days prior to leukapheresis. * Receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to leukapheresis. Inclusion Criteria for CRC01 Infusion: * No clinically significant worsening of organ function after screening. * If any of the following adverse events related to lymphodepleting chemotherapy exceed Grade 1 or worsen compared with screening, CRC01 infusion must be delayed: * Requirement for supplemental oxygen * New arrhythmia symptoms or clinically significant changes in cardiac function compared with screening * Hypotension requiring treatment * Active infection within 72 hours prior to the planned CRC01 infusion * If bacterial, viral, or fungal infection is documented, improvement of symptoms must be documented before infusion. * Women of childbearing potential must have a negative urine pregnancy test prior to infusion. * If CRC01 infusion is delayed for more than 2 weeks after lymphodepleting chemotherapy, administration may proceed only with approval from the sponsor's medical monitor. * No receipt of therapeutic doses of systemic corticosteroids or immunosuppressive agents within 7 days prior to CRC01 infusion. (Prednisone ≤7.5 mg/day or equivalent is permitted.) * No receipt of antibody-based therapies (e.g., belimumab, rituximab, anifrolumab) within 4 weeks prior to CRC01 infusion.