Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy
NCT ID: NCT07266181
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
5 participants
INTERVENTIONAL
2025-12-08
2028-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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To preliminarily evaluate the safety and efficacy of CD19 CAR-T in refractory membranous nephropathy
All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment.
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.
Interventions
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All patients will receive CD19 CAR-T cell therapy on the basis of standard symptomatic and supportive treatment.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Air Force Medicial University
OTHER
Responsible Party
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Li Jipeng
Research associate
Locations
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Department of Nephrology, Xijing Hospital
Xi'an, China, China
Countries
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Central Contacts
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Facility Contacts
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Jipeng Li
Role: primary
Provided Documents
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Document Type: Study Protocol: English Translation Version
Document Type: Study Protocol: in Simplified Chinese
Document Type: Informed Consent Form: English Translation Version
Document Type: Informed Consent Form: in Simplified Chinese
Other Identifiers
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KY20252388-F-1
Identifier Type: -
Identifier Source: org_study_id