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Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy

Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) in the Treatment of Refractory Membranous Nephropathy

NCT07266181•The First Affiliated Hospital of Air Force Medicial University

View on ClinicalTrials.gov

Summary

This study is a single-center, prospective, exploratory Phase I clinical trial initiated by the team led by Associate Professor He Lijie from the Department of Nephrology, Xijing Hospital. Prior to receiving CAR-T cell therapy, patients will undergo lymphodepletion chemotherapy with cyclophosphamide (fludarabine will be added if necessary). After prophylactic administration of antihistamines and acetaminophen, patients will be infused with CD19 CAR-T cells at a dose of 1×10⁶ cells/kg. In the subsequent 2 weeks, patients will be hospitalized for monitoring of vital signs and adverse reactions. The planned follow-up duration of this study is 1 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed as primary membranous nephropathy (PMN) by renal biopsy.
•Classified as moderate-risk or high-risk refractory membranous nephropathy (rMN).
•Moderate-risk rMN is defined as: eGFR ≥ 90 ml/min/1.73m² AND 24-hour urinary protein \> 3.5g/d, with a reduction of no more than 50% within 6 months of receiving renin-angiotensin system inhibitor (RASi) therapy.
•High-risk rMN is defined as meeting one of the following:
•1. eGFR \< 60 ml/min/1.73m² and/or persistent proteinuria \> 8g/d for more than 6 months.
•2. Normal eGFR with proteinuria \> 3.5g/d and ≤50% reduction after 6 months of RASi therapy, PLUS at least one of the following: Serum albumin \< 25g/L; PLA2R antibody \> 50 RU/mL; Urinary α1-microglobulin \> 40 μg/min; Urinary IgG \> 1 μg/min; Urinary β2-microglobulin \> 250 mg/d; IgG/albumin clearance ratio \> 0.20.
•Diagnosis of rMN requires failure of adequate first-line immunosuppressive therapy (≥6 months of steroids+cyclophosphamide, CNI, or rituximab), defined by any of the following: persistent high-titer anti-PLA2R antibody; for antibody-negative patients, persistent nephrotic syndrome (protein \>3.5g/d, albumin \<30g/L); \<50% reduction in proteinuria.
•Age ≥ 18 years.
•Adequate organ function, defined as:
•1. Renal: eGFR ≥ 30 ml/min/1.73m².
+4 more criteria

Exclusion Criteria

•Secondary membranous nephropathy (e.g., due to SLE, malignancy, drugs, infection).
•Active infection requiring IV antibiotics, active tuberculosis, or positive viral serology indicating active infection, including:
•1. HBV: HBsAg (+) and/or HBcAb (+) with detectable HBV DNA.
•2. HCV: HCV Ab (+) with detectable HCV RNA.
•3. HIV Ab (+).
•4. Active EBV or CMV infection (IgM+ or DNA above normal).
•5. Positive syphilis (Treponema pallidum) antibody (requires evaluation for active infection).
•Severe uncontrolled comorbidities, including:
•1. Uncontrolled hypertension (persistent SBP \> 160 mmHg or DBP \> 100 mmHg).
•2. Uncontrolled diabetes (HbA1c \> 8% or random glucose ≥11.1 mmol/L) or diabetic nephropathy.
+15 more criteria

Locations (1)

Department of Nephrology, Xijing Hospital

Xi'an, China, China

Key Dates

Start Date

December 8, 2025

Primary Completion Date

July 31, 2027

Completion Date

July 31, 2028

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Refractory Membranous Nephropathy

Interventions

All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment.

OTHER

Contacts

Jipeng Li

CONTACT

8684775197 shaona@ldy.edu.rs