This study is a single-arm, single-center, open-label, dose-escalation exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of CD19 CAR-γδ T cells. The subjects enrolled in this study are patients with relapsed/refractory autoimmune nephropathy, including lupus nephritis, IgA nephropathy, and membranous nephropathy. This study adopts a standard "3+3" design to assess the recommended dose (RD) and identify dose-limiting toxicities (DLTs). The treatment process is as follows: subjects who meet the inclusion criteria will receive lymphodepletion conditioning, followed by a single intravenous infusion of CD19 CAR-γδ T cells. The primary objective of this study is to evaluate the safety profile of this cellular therapy, including the incidence of DLTs, maximum tolerated dose (MTD) or RD, as well as the incidence and severity of treatment-related adverse events and clinically significant abnormal laboratory test results after CAR-γδ T cell infusion (including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The planned follow-up duration of this study is 1 years.
Age ≥18 years and ≤65 years;
Agree to participate in this study and sign the informed consent form;
Liver function: ALT, AST or ALP level ≤3 × ULN (upper limit of normal), bilirubin ≤2 × ULN;
Renal function: eGFR ≥30 mL/min/1.73m²;
Subjects with life-threatening conditions (e.g., catastrophic antiphospholipid syndrome, acute severe renal failure) assessed by the investigator as unsuitable for enrollment in this study;
History of alcohol or drug abuse within 24 weeks prior to screening;
History of malignant tumors other than B-cell lymphoma, except for the following: malignancies confirmed to be cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, and carcinoma in situ at any site;
Major surgery (including joint surgery) within 24 weeks prior to screening, or planned surgery within 24 weeks after enrollment;
Single group
CD19 CAR-γδ T cell
Biological/VaccinePrior to CAR-γδ T cell infusion, patients will receive lymphodepleting chemotherapy consisting of cyclophosphamide combined with fludarabine, followed by infusion of CD19 CAR-γδ T cells at the assigned dose level per their dose-escalation cohort, with target total cell doses of 3×10\^7, 1×10\^8, and 3×10\^8 cells, respectively.
Incidence of Dose-Limiting Toxicities (DLTs)
The number, frequency, and severity of DLTs experienced by subjects after the first infusion of CD19 CAR-γδ T cells. DLTs are defined by NCI-CTCAE 5.0 and ASTCT consensus for CRS and neurotoxicity.
Incidence of Adverse Events (AEs)
Evaluation of the number, frequency, and severity of all adverse events, including Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs).
Preliminary Clinical Efficacy for Lupus Nephritis
Proportion of subjects achieving complete renal response, major renal response, and partial renal response.
Preliminary Clinical Efficacy for IgA Nephropathy
Proportion of subjects with 24-hour urine protein quantification below the threshold of 0.3g/24h.
Preliminary Clinical Efficacy for Membranous Nephropathy
Proportion of subjects achieving complete remission (CR) or partial remission (PR).
The degree of B cell depletion
The degree of B cell depletion at various time points
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