The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases
Trial Parameters
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Brief Summary
This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\^6 cells/kg, 1.0×10\^6 cells/kg, 3.0×10\^6 cells/kg, and an alternative dose of 0.1×10\^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).
Eligibility Criteria
Inclusion Criteria: 1. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study. 2. Participants must be aged ≥18 and ≤65 years. 3. Disease-specific inclusion criteria: Active, relapsing, refractory Lupus Nephritis (LN): LN diagnosed by kidney biopsy within the last 2 years, with pathological types III, IV, or V, and a chronicity index (CI) score≤3 Meets one of the following criteria: Refractory LN, defined as no remission after at least one standard regimen (CTX and/or MMF) for 6 months. Relapsing LN, defined as a need to increase steroid dosage to control disease activity during maintenance treatment. Clinical criteria: eGFR \> 45 ml/min/1.73 m²; urinary protein quantification ≥ 1.5g/24h; SLE-DAI score ≥ 8. ANCA-associated vasculitis (AAV) patients: Diagnosed as AAV according to the 2012 Chapel Hill Consensus Conference criteria, meeting one of the following: Newly diagnosed AAV with renal involvement: Renal involvement