Actively Recruiting
Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy
Led by The First Affiliated Hospital of Air Force Medicial University · Updated on 2025-12-24
5
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of primary membranous nephropathy by kidney biopsy.
- Classified as moderate-risk or high-risk refractory membranous nephropathy.
- Moderate-risk defined as eGFR ≥ 90 ml/min/1.73m² and proteinuria > 3.5g/day with less than 50% reduction after 6 months of renin-angiotensin system inhibitor therapy.
- High-risk defined by eGFR < 60 ml/min/1.73m² and/or persistent proteinuria > 8g/day for over 6 months or normal eGFR with proteinuria > 3.5g/day plus specific laboratory markers.
- Failure of at least 6 months of first-line immunosuppressive therapy including steroids with cyclophosphamide, calcineurin inhibitors, or rituximab.
- Age 18 years or older.
- Adequate organ function including kidney, liver, heart, and lung criteria.
- Ability to understand and willing to sign informed consent.
You will not qualify if you...
- Secondary membranous nephropathy caused by conditions such as lupus, cancer, drugs, or infection.
- Active infections requiring intravenous antibiotics or positive viral tests for hepatitis B, hepatitis C, HIV, EBV, CMV, or syphilis.
- Severe uncontrolled conditions including hypertension, diabetes, recent blood clots, active ulcers, severe immune deficiency, serious central nervous system diseases, or end-stage organ failure unrelated to membranous nephropathy.
- History of cancer within the last 5 years except certain treated skin, cervical, or thyroid cancers.
- Prior cell therapy treatments or recent/planned major surgery.
- Planned kidney transplantation within 3 years.
- History of substance abuse.
- Participation in another interventional clinical trial within 3 months.
- Pregnant or breastfeeding women.
- Inability to understand the study or provide consent due to mental illness or severe dementia.
- Any other condition considered by investigators to increase risk or interfere with the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Nephrology, Xijing Hospital
Xi'an, China, China, 710012
Actively Recruiting
Research Team
J
Jipeng Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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