Actively Recruiting
An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA U CAR-T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease
Led by Changhai Hospital · Updated on 2026-02-06
36
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease
CONDITIONS
Official Title
An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA U CAR-T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Detectable CD19 positive B cells in peripheral blood by flow cytometry
- Adequate organ function including neutrophil count ≥1 x 10^9/L, hemoglobin ≥60 g/L, platelets ≥50 x 10^9/L
- Liver function within 3 times the normal upper limit for ALT and AST, bilirubin ≤1.5 times normal upper limit
- Coagulation parameters INR ≤1.5 times upper limit, prothrombin time ≤1.5 times upper limit
- Good cardiac function with left ventricular ejection fraction ≥55%
- Willingness to use contraception or abstain from sex for at least 6 months during and after treatment; females of childbearing potential must have a negative pregnancy test within 7 days before enrollment and not be breastfeeding
- Voluntary participation with informed consent, good compliance, and cooperation with follow-up
- Diagnosis of high-risk or relapsed/refractory primary membranous nephropathy confirmed by kidney biopsy
- Meets clinical criteria for high-risk or recurrent/refractory membranous nephropathy with specified kidney function and proteinuria thresholds
- Primary IgA nephropathy confirmed by kidney biopsy
- Stable, maximally tolerated ACEI or ARB treatment for at least 3 months before screening
- Prior treatment with hormones, cytotoxic drugs, immunosuppressants, or biologics for more than 6 months with persistent proteinuria or relapse
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening
- Diagnosis of ANCA-associated vasculitis meeting 2022 ACR/EULAR criteria with active disease (BVAS ≥15) and kidney involvement
- Positive ANCA antibodies (MPO-ANCA or PR3-ANCA)
- Relapsed or refractory disease after standard treatments including glucocorticoids and immunomodulatory drugs
You will not qualify if you...
- Allergies or severe reactions to CAR T therapy components or related drugs including fludarabine, cyclophosphamide, or tocilizumab
- Active or uncontrolled infections of fungal, bacterial, viral, or other origins
- Central nervous system disorders such as epilepsy, psychiatric conditions, or brain diseases
- Serious heart conditions including angina, myocardial infarction, heart failure, or arrhythmias
- Congenital immunoglobulin deficiencies
- Other malignant tumors except certain skin, cervical, bladder, or breast cancers with long disease-free survival
- End-stage renal failure
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with detectable viral loads
- Mental illness or severe cognitive impairment
- Participation in other clinical trials within 6 months prior to enrollment
- Pregnancy or planning to conceive
- Uncontrolled hypertension or diabetes
- Secondary membranous nephropathy or other renal diseases confirmed by biopsy
- Secondary IgA nephropathy or other specific renal diseases
- Crescentic nephritis with >50% crescent bodies
- Estimated glomerular filtration rate (eGFR) below 15 mL/min/1.73 m2
- Alveolar hemorrhage requiring invasive lung ventilation exceeding screening duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
Z
Zhiyong Guo, Dr
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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