Actively Recruiting
Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-20
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To study the safety and effectiveness of cord blood-derived IL-10/IL-15 CD19-CAR NK in patients with B-cell non-Hodgkin's lymphoma
CONDITIONS
Official Title
Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign informed consent
- Age between 18 and 75 years, any gender
- Histologically confirmed diagnosis of specific B-cell NHL subtypes with refractory or relapsed disease as defined
- At least one measurable lesion measuring 1.5 cm or greater
- Expected survival of at least 12 weeks
- Tumor tissue positive for CD19 expression
- ECOG performance status score between 0 and 2
- Adequate organ function including liver enzymes, kidney function, bilirubin, heart function, and oxygen saturation
- Previous stem cell transplantation allowed
- Completed approved anti-B-cell lymphoma treatments at least 3 weeks before study drug
- Prior CAR-T therapy allowed if failed or relapsed after 3 months
- Female participants of childbearing potential must have negative pregnancy test and agree to contraception
- Two negative tests for new coronavirus
You will not qualify if you...
- History of allergies to ingredients in cell products
- History of other tumors
- History of moderate to severe acute or extensive chronic graft-versus-host disease or receiving treatment for it
- Gene therapy within past 3 months
- Active infections requiring treatment (except simple urinary tract infections or bacterial pharyngitis)
- Hepatitis B, hepatitis C, syphilis, HIV, or other immunodeficiency conditions
- Severe heart dysfunction classified as NYHA Grade III or IV
- Unresolved toxic reactions from previous anti-tumor therapy except certain mild symptoms
- History of epilepsy or central nervous system diseases
- Evidence of central nervous system lymphoma on imaging
- Use of other drugs targeting CD19
- Breastfeeding and unwilling to stop
- Any condition increasing risk or interfering with study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
W
Wenbin Qian, Professor
CONTACT
H
Hui Liu, Doctor
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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