Actively Recruiting
Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-08-29
18
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS
CONDITIONS
Official Title
Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 years or older, any gender
- Diagnosed with steroid-resistant nephrotic syndrome (SRNS) per 2021 KDIGO guidelines, with no complete response after 12 months of two hormone replacement drugs or relapse after remission; or no remission after 3-6 months of calcineurin inhibitor treatment with investigator approval
- Kidney biopsy confirming minimal lesion nephropathy (MCD) or focal segmental glomerulosclerosis (FSGS)
- Normal important organ functions: heart (LVEF 65%, no ECG abnormalities), kidney (eGFR 60 mL/min/1.73m2), liver (AST and ALT 3.0 times upper normal limit, TBIL 2.0 times upper normal limit), lung (no serious lesions, SpO2 92%)
- Eligible for leukapheresis or intravenous blood collection with no contraindications
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception for one year after CAR-T infusion
- Willingness to participate and signed informed consent
You will not qualify if you...
- Prior CAR-T cell therapy or gene-modified cell therapy
- History of cerebrovascular accident, seizure, or active central nervous system disease within 6 months
- Genetic confirmation of hereditary kidney disease
- Kidney biopsy showing IgA nephropathy, idiopathic membranous nephropathy, or membranoproliferative glomerulonephritis
- Received or currently receiving renal replacement therapy within 3 months before infusion
- History of congenital heart disease, recent acute myocardial infarction, severe arrhythmias, pericardial effusion, myocarditis, or unstable vital signs needing hypertensive drugs
- Received solid organ or hematopoietic stem cell transplant within 3 months or acute graft-versus-host disease grade 2 or higher within 2 weeks
- Positive for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus infections beyond normal reference ranges
- Macrophage activation syndrome within 1 month
- Received live vaccine within 4 weeks
- Malignant tumors or other serious life-threatening diseases
- Positive blood pregnancy test
- Participation in other clinical studies within 1 month
- Any condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jianhua Mao, PhD
CONTACT
G
Guoping Huang, MD
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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