Actively Recruiting
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cell Therapy in Patients With MDR-SRNS
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-05-07
18
Participants Needed
1
Research Sites
141 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-CD19 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS
CONDITIONS
Official Title
Study of Therapeutic Efficacy of Anti-CD19 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 and not fully responsive after 12 months of treatment with two standard hormone replacement drugs or relapse after remission
- Renal biopsy confirming minimal lesion nephropathy (MCD) or focal segmental glomerulosclerosis (FSGS)
- Normal major organ functions including cardiac, renal, liver, and lung functions within specified limits
- Eligible for leukapheresis or intravenous blood collection with no contraindications
- Negative pregnancy test for females of childbearing age and agreement to use effective contraception for one year after CAR-T infusion
- Participant or guardian agrees to sign informed consent and understands the study purpose and procedures
You will not qualify if you...
- Previously received CAR T cell therapy or other gene-modified cell therapy
- Cerebrovascular accident, seizure, or active central nervous system disease within 6 months
- Confirmed hereditary kidney disease by genetic tests
- Renal biopsy showing immunoglobulin A nephropathy, idiopathic membranous nephropathy, or membranoproliferative glomerulonephritis
- Renal replacement therapy within 3 months prior to transfusion (with exceptions under investigator's discretion)
- History of congenital heart disease, recent acute myocardial infarction, severe arrhythmias, or unstable vital signs requiring hypertensive drugs
- Received solid organ or hematopoietic stem cell transplantation within 3 months prior to screening
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus above normal reference ranges
- Macrophage activation syndrome within 1 month prior to screening
- Received live vaccine within 4 weeks before screening
- Malignant tumors or other serious life-threatening diseases
- Positive blood pregnancy test
- Participation in another clinical study within 1 month prior to enrollment
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
J
Jianhua Mao, PhD
CONTACT
G
Guoping Huang, MM
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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