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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of cord blood-derived IL-10/IL-15 CD19-CAR NK cells in adults aged 18 to 75 years with certain types of refractory or relapsed B-cell non-Hodgkin lymphoma. This early-phase trial focuses on patients who have not responded to previous treatments or have relapsed, aiming to determine the best dose and assess side effects as well as tumor response and survival outcomes. Participants receive intravenous infusions of the IL-10/IL-15 CD19-CAR NK cells on days 0, 3, and 6. The trial begins with a dose-escalation phase involving 6 to 24 patients to find the recommended dose by testing three different cell doses. Following this, an additional 30 patients will receive the recommended dose in a dose-expansion phase to further evaluate safety and effectiveness. Throughout the study, participants will be closely monitored for dose-limiting toxicities during the first 28 days after treatment. Researchers will also track treatment responses, progression-free survival, overall survival, and duration of response for up to two years. Assessments include evaluating measurable tumors, organ function, and overall health status. The study team will follow safety and efficacy outcomes to better understand this treatment's potential in lymphoma care.
CONDITIONS
Brief 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
- Diagnosed with diffuse large B-cell lymphoma, transforming follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma, or other indolent B-cell NHL types with refractory or relapsed disease
- Have received prior CD20 monoclonal antibody treatment (unless CD20 negative) and anthracycline therapy
- At least one measurable tumor lesion 1.5 cm or larger
- Expected survival of 12 weeks or more
- Tumor tissue positive for CD19 expression
- ECOG performance status score between 0 and 2
- Adequate organ function including liver enzymes, kidney function, bilirubin, cardiac ejection fraction, and oxygen saturation
- Previous stem cell transplantation allowed
- Completed 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
- Negative tests for new coronavirus (COVID-19)
You will not qualify if you...
- Allergy history to any ingredients in the cell product
- History of other tumors
- Moderate to severe acute or extensive chronic graft-versus-host disease or receiving treatment for it
- Gene therapy within the past 3 months
- Active infections requiring treatment (except simple urinary tract infections or bacterial pharyngitis)
- Hepatitis B or C infection, syphilis, or immunodeficiency diseases including HIV
- Severe heart dysfunction (NYHA class III or IV)
- Unresolved toxicity 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 CT or MRI
- Use of other drugs targeting CD19
- Breastfeeding and unwilling to stop
- Any other condition increasing risk or interfering with study results as judged by investigator
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 - 1 week
Participants receive intravenous infusions of IL-10/IL-15 CD19-CAR NK cells on Day 0, Day 3, and Day 6 as part of the dose-escalation and dose-expansion protocol.
3 infusion visits within one week
Duration - Up to 2 years
Participants are monitored for safety, response, and survival outcomes up to 2 years after treatment.
Regular visits for safety and efficacy assessments
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
H
Hui Liu, Doctor
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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