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
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 CAR-NK cells that target CD19 in patients with refractory or relapsed B-cell non-Hodgkin's lymphoma (NHL). This open, single-arm, dose-escalation phase 1 trial plans to enroll 9 to 18 patients initially to determine the best dose, followed by an additional 30 patients treated with that dose to further assess safety and efficacy. The main focus is on dose-limiting toxicities and overall response rates, including complete and partial responses, overall survival, and progression-free survival. Participants receive a single intravenous infusion of the investigational CB CAR-NK019 cells at one of several dose levels ranging from 2 million to 4 million cells per kilogram. After dose escalation identifies the recommended dose, more patients will receive this dose to better understand treatment effects. The study monitors patients closely for adverse effects and responses up to two years after treatment. During the study, participants will undergo regular evaluations including physical exams, tumor tissue testing for CD19 expression, organ function tests, and imaging studies to assess tumor size and response. Researchers will track safety outcomes such as dose-limiting toxicity within 28 days, and long-term measures like progression-free survival and overall survival for up to two years. Pregnancy tests and COVID-19 tests are also conducted as part of safety monitoring. Overall participation may last up to two years with ongoing follow-up visits.
CONDITIONS
Brief 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 an informed consent form
- Age between 18 and 75 years, any gender
- Histologically diagnosed with specific B-cell non-Hodgkin lymphomas including DLBCL, TFL, PMBCL, MCL, or other inert B-cell NHL conversion types
- Refractory or relapsed disease after specified prior treatments, including CD20 monoclonal antibody and anthracyclines (unless CD20 negative)
- At least one measurable lesion with longest diameter ≥ 1.5 cm
- Expected survival of 12 weeks or more
- Tumor tissue positive for CD19 expression
- ECOG performance status score between 0 and 2
- Sufficient organ function including liver enzymes ≤ 2.5× upper limit normal, creatinine clearance ≥ 60 mL/min, bilirubin and alkaline phosphatase ≤ 1.5× upper limit normal, glomerular filtration rate > 50 mL/min, cardiac ejection fraction ≥ 50%, oxygen saturation > 92%
- Completed approved anti-B-cell lymphoma treatments at least 3 weeks prior
- Allowed previous stem cell transplantation and prior CAR-T therapy if relapsed or failed after 3 months
- Female participants of childbearing age must have a negative pregnancy test and agree to contraception
- Two negative tests for the new coronavirus
You will not qualify if you...
- History of allergies to any ingredients in cell products
- History of other tumors
- Prior II-IV degree acute or extensive chronic graft-versus-host disease or ongoing anti-GvHD treatment
- Gene therapy within past 3 months
- Active infections needing treatment except simple urinary tract infections or bacterial pharyngitis
- Hepatitis B or C infection, syphilis, or immunodeficiency diseases including HIV
- Heart function classified as Grade III or IV by NYHA standards
- Toxic reactions from prior anti-tumor therapy not recovered to grade ≤1 except fatigue, anorexia, hair loss
- History of epilepsy or other central nervous system diseases
- Evidence of central nervous system lymphoma on imaging
- Prior use of other drugs targeting CD19
- Currently breastfeeding and unwilling to stop
- Any condition that may increase risk or affect study results as judged by investigators
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 - Single dose with safety evaluation up to 28 days
Participants receive a single intravenous dose of cord blood-derived CAR-NK cells targeting CD19 to treat refractory or relapsed B-cell non-Hodgkin lymphoma.
Multiple visits during the first 28 days for safety monitoring
Duration - Up to 2 years
Participants are monitored for safety and treatment efficacy, including response rates, progression-free survival, and overall survival.
Regular visits for assessments over 2 years
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
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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