CD19 CAR-T therapy for refractory primary membranous nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective Phase I trial tests the safety and preliminary efficacy of CD19 CAR-T cells in refractory primary membranous nephropathy. Participants receive lymphodepletion with cyclophosphamide (with fludarabine added if needed), followed by prophylaxis with antihistamines and acetaminophen and a single infusion of CD19 CAR-T cells at 1 × 10^6 cells/kg. Patients are hospitalized for about two weeks for close monitoring of vital signs and adverse reactions and are followed for one year to track kidney function, proteinuria, and immune markers. The trial is exploratory and is primarily focused on safety with secondary observations of clinical and serologic responses.

Why it matters

Who can join: the full rules

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.
  2. Hepatic: ALT and AST ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN.
  3. Cardiac: LVEF ≥ 50%; NYHA Class I or II; No significant arrhythmias requiring intervention; No major cardiovascular events within the past 6 months.
  4. Respiratory: SpO2 \> 92% on room air.
* Ability to understand and willingness to sign an Informed Consent Form.

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.
  3. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months.
  4. Active peptic ulcer or gastrointestinal bleeding within the past 6 months.
  5. Severe congenital or acquired immunodeficiency.
  6. Severe CNS diseases (e.g., catastrophic APS, uncontrolled epilepsy).
  7. End-stage organ failure not attributable to PMN.
* History of malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid cancer.
* Specific treatment history or plans, including:

  1. Prior receipt of any cell therapy (e.g., MSCs, HSCT).
  2. Major surgery within 24 weeks before or planned within 24 weeks after enrollment.
  3. Planned kidney transplantation within 3 years.
  4. History of substance abuse.
* Participation in another interventional clinical trial within 3 months prior to enrollment.
* Pregnant or lactating women.
* Inability to understand the study or provide informed consent (e.g., severe dementia, mental illness).
* Any other condition deemed by the investigator to increase risk, interfere with assessment, or affect compliance.

Where it's running

• Department of Nephrology, Xijing Hospital
  Xi'an, China, China Recruiting

Study contacts

• Study coordinator: Jipeng Li
• Email: shaona@ldy.edu.rs
• Phone: 8684775197

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.