Actively Recruiting
An Exploratory Clinical Study of Anti-CD19 CAR NK Cell (KN5501) in the Treatment of Relapsed/Refractory Immune Nephropathy
Led by Changhai Hospital · Updated on 2025-04-30
36
Participants Needed
1
Research Sites
104 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 CAR NK cell injection (KN5501) in patients with immune nephropathy. 36 patients are planned to be enrolled in the dose-escalation trial. The primary endpoints are DLT and TEAEs. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR)
CONDITIONS
Official Title
An Exploratory Clinical Study of Anti-CD19 CAR NK Cell (KN5501) in the Treatment of Relapsed/Refractory Immune Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, male or female
- Positive CD19 expression in peripheral blood B cells confirmed by flow cytometry
- Adequate bone marrow function: white blood cell count 3 x 10^9/L, neutrophil count 1 x 10^9/L without colony-stimulating factor treatment in past 2 weeks, hemoglobin 60 g/L
- Liver function within limits: ALT 3 times upper limit of normal (ULN), AST 3 x ULN, total bilirubin 1.5 x ULN (or 3.0 x ULN if Gilbert syndrome)
- Coagulation function: INR 1.5 x ULN, prothrombin time 1.5 x ULN
- Good cardiac function with left ventricular ejection fraction 55%
- Use of approved contraception or abstinence for 6 months during and after study if of childbearing potential; negative serum HCG test within 7 days prior to enrollment; not lactating
- Voluntary participation with signed informed consent, good compliance, and cooperation with follow-up
- Specific criteria for recurrent/refractory primary membranous nephropathy, IgA nephropathy, or ANCA-associated vasculitis as detailed in the protocol
You will not qualify if you...
- Known severe allergic reactions or contraindications to cyclophosphamide, fludarabine, or tozumabs
- Uncontrolled or treatable fungal, bacterial, viral or other infections
- Central nervous system disorders including epilepsy, psychiatric disorders, encephalopathy, cerebrovascular accidents, encephalitis, or CNS vasculitis
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia
- Congenital immunoglobulin deficiency
- Malignant tumors except certain skin or in situ cancers disease-free for over 5 years
- End-stage renal failure
- Positive hepatitis B surface antigen or core antibody with high HBV DNA, positive hepatitis C virus antibodies and RNA, HIV positive, or syphilis positive
- Mental illness or severe cognitive impairment
- Participation in other clinical trials within the past 3 months
- Pregnant or intending to conceive women
- Secondary membranous nephropathy or other combined renal diseases confirmed by biopsy
- Type 1 or type 2 diabetes
- Secondary IgA nephropathy or specific pathological renal diseases
- Estimated glomerular filtration rate (eGFR) below specified limits for each nephropathy type
- Requirement for invasive lung ventilation due to alveolar hemorrhage lasting beyond screening period
- Any other investigator-determined reasons precluding participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changhai hospital
Shanghai, China
Actively Recruiting
Research Team
Q
Qi Bian, M.D.
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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