Actively Recruiting
Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-03-04
48
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To study the safety and effectiveness of cord blood-derived CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma
CONDITIONS
Official Title
Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 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 diffuse large B-cell lymphoma, transforming follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma, or other indolent B-cell NHL conversion types
- Refractory or relapsed disease as defined by specific treatment failure or progression timelines
- Previous treatment includes CD20 monoclonal antibody (unless CD20 negative) and anthracyclines
- At least one measurable lesion with longest diameter ≥ 1.5 cm
- 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 ≤ 2.5× upper normal limit, creatinine clearance ≥ 60 mL/min, bilirubin and alkaline phosphatase ≤ 1.5× upper normal limit, glomerular filtration rate > 50 mL/min, cardiac ejection fraction ≥ 50%, oxygen saturation > 92%
- Prior stem cell transplantation allowed
- Completed approved anti-B-cell lymphoma treatments at least 3 weeks before study drug
- Previous CAR-T therapy allowed if relapse or failure after 3 months
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Two negative tests for new coronavirus
You will not qualify if you...
- History of allergy to any ingredients in cell products
- History of other tumors
- Previous grade II-IV acute graft-versus-host disease or extensive chronic graft-versus-host disease or receiving anti-GvHD treatment
- Gene therapy within past 3 months
- Active infections requiring treatment except simple urinary tract infection or bacterial pharyngitis
- Hepatitis B or C infection carriers, syphilis, or acquired/congenital immunodeficiency including HIV
- New York Heart Association Heart Function Class III or IV
- Unrecovered toxic reactions from prior anti-tumor therapy (except fatigue, anorexia, hair loss)
- History of epilepsy or other central nervous system diseases
- Evidence of central nervous system lymphoma on imaging
- Received other drugs targeting CD19
- Breastfeeding and unwilling to stop breastfeeding
- Any other 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
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
W
Wenbin Qian
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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