Actively Recruiting
An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19 CAR NK Cell Injections (KN5501) in Treating Relapsed/Refractory Immune Nephropathy
Led by Changhai Hospital · Updated on 2025-04-30
36
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of anti-CD19 CAR NK cell injections (KN5501) in patients with relapsed or refractory immune nephropathy. This early phase 1, open-label pilot study plans to enroll 36 patients to explore dose-limiting toxicities and treatment emergent adverse events, as well as overall response rates and disease control rates. Participants will receive pre-treatment with Fludarabine and Cyclophosphamide on days -5, -4, and -3. Then, multiple doses of anti-CD19 CAR NK cells will be infused using a "3 + 3" dose-escalation approach to determine the best dosing. The study focuses on monitoring safety and evaluating responses to this biological treatment. During the study, participants will be followed for up to 48 weeks after infusion to assess toxicities and adverse events. Response rates, disease control, and B cell levels will be checked at 1, 3, 6, and 12 months post-infusion. Participants will be monitored closely for safety and treatment effects, with follow-up visits and laboratory tests throughout the study period.
CONDITIONS
Brief 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 (no colony-stimulating factor treatment within 2 weeks), hemoglobin ≥ 60 g/L
- Liver function within limits: ALT ≤ 3 x ULN, AST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (excluding Gilbert syndrome), total bilirubin ≤ 3.0 x ULN
- Coagulation function within limits: INR ≤ 1.5 x ULN, prothrombin time ≤ 1.5 x ULN
- Good cardiac function with left ventricular ejection fraction ≥ 55%
- Use of medically approved contraception or abstinence for 6 months during and after treatment for females of childbearing potential and their male partners
- Negative serum HCG test within 7 days before enrollment for females of childbearing potential; not lactating
- Voluntary participation with informed consent and ability to comply with follow-up
- Specific criteria for recurrent/refractory primary membranous nephropathy, relapsed/refractory IgA nephropathy, or relapsed/refractory ANCA-associated vasculitis as detailed in the protocol
You will not qualify if you...
- Severe allergic reactions or hypersensitivity to cyclophosphamide, fludarabine, tozumabs, or any trial medication
- Uncontrolled or treatable fungal, bacterial, viral, or other infections
- Central nervous system disorders including epilepsy, psychiatric disorders, encephalopathy, cerebrovascular accidents, or vasculitis
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia
- Congenital immunoglobulin deficiency
- Malignant tumors except certain skin and in situ cancers disease-free for over 5 years
- End-stage renal failure
- Positive hepatitis B, hepatitis C, HIV, or syphilis infection markers above specified thresholds
- Mental illness or severe cognitive impairment
- Participation in other clinical trials within 3 months
- Pregnant or intending to conceive women
- Secondary membranous nephropathy or other specified renal diseases depending on nephropathy type
- Type 1 or type 2 diabetes
- Specific exclusions for IgA nephropathy and ANCA-associated vasculitis as detailed in the protocol
- Investigator's judgment of inability to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment duration includes chemotherapy on days -5 to -3 and multiple CAR NK cell infusions thereafter.
Participants receive conditioning chemotherapy with Fludarabine and Cyclophosphamide followed by multiple doses of anti-CD19 CAR NK cells (KN5501) using a dose-escalation strategy.
Multiple visits for infusions and monitoring during treatment
Duration - Up to 48 weeks after infusion
Participants are monitored for safety and efficacy including assessment of adverse events and disease response up to 48 weeks after infusion.
Visits at 1, 3, 6, and 12 months after infusion
Trial Site Locations
Total: 1 location
1
Shanghai Changhai hospital
Shanghai, China
Actively Recruiting
Research Team
Q
Qi Bian, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here