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Tests treatment safety and results for Refractory Membranous Nephropathy
Official title Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy
ClinicalTrials.gov ID: NCT07266181
What this study is testing
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- High-risk rMN is defined as meeting one of the following:
- eGFR \ 8g/d for more than 6 months.
You likely can't join if
- 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:
- HBV: HBsAg (+) and/or HBcAb (+) with detectable HBV DNA.
- HCV: HCV Ab (+) with detectable HCV RNA.
- HIV Ab (+).
- Active EBV or CMV infection (IgM+ or DNA above normal).
See the full eligibility 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:
- eGFR \ 8g/d for more than 6 months.
- 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 \ 50 RU/mL; Urinary α1-microglobulin \> 40 μg/min; Urinary IgG \> 1 μg/min...
- 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...
- Age ≥ 18 years.
- Adequate organ function, defined as:
- Renal: eGFR ≥ 30 ml/min/1.73m².
- Hepatic: ALT and AST ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN.
- Cardiac: LVEF ≥ 50%; NYHA Class I or II; No significant arrhythmias requiring intervention; No major cardiovascular events within the past 6 months.
- Respiratory: SpO2 \> 92% on room air.
- Ability to understand and willingness to sign an Informed Consent Form.
- 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:
- HBV: HBsAg (+) and/or HBcAb (+) with detectable HBV DNA.
- HCV: HCV Ab (+) with detectable HCV RNA.
- HIV Ab (+).
- Active EBV or CMV infection (IgM+ or DNA above normal).
- Positive syphilis (Treponema pallidum) antibody (requires evaluation for active infection).
- Severe uncontrolled comorbidities, including:
- Uncontrolled hypertension (persistent SBP \> 160 mmHg or DBP \> 100 mmHg).
- Uncontrolled diabetes (HbA1c \> 8% or random glucose ≥11.1 mmol/L) or diabetic nephropathy.
- Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months.
- Active peptic ulcer or gastrointestinal bleeding within the past 6 months.
- Severe congenital or acquired immunodeficiency.
- Severe CNS diseases (e.g., catastrophic APS, uncontrolled epilepsy).
- 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:
- Prior receipt of any cell therapy (e.g., MSCs, HSCT).
- Major surgery within 24 weeks before or planned within 24 weeks after enrollment.
- Planned kidney transplantation within 3 years.
- History of substance abuse.
- Participation in another treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.