Actively Recruiting
CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Led by Zhejiang University · Updated on 2026-04-07
40
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
CONDITIONS
Official Title
CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age no less than 18, no gender limit
- Newly diagnosed high-risk Large B-cell Lymphoma defined by: (1) DLBCL with IPI score 653, (2) high grade B-cell lymphoma with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified
- Confirmed CD19 and CD20 positive expressions in lymphoma cells
- ECOG performance status score between 0 and 2
- Total bilirubin 64 51 umol/L, ALT and AST 64 3 times upper limit of normal, creatinine 64 176.8 umol/L
- Left ventricular ejection fraction 6550% by echocardiogram
- No active lung infection and blood oxygen saturation 65% in indoor air
- Estimated survival time 653 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Central nervous system involvement by lymphoma; history of craniocerebral trauma, consciousness disturbance, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Electrocardiogram showing prolonged QT interval or history of severe arrhythmia or severe heart disease
- Severe active infections excluding simple urinary tract infection and bacterial pharyngitis
- Active hepatitis B or C virus infection
- Previous treatment with any CAR-T cell or genetically modified T cell therapies
- Insufficient amplification response to CD3/CD28 co-stimulus signal (<5 times)
- Other uncontrolled diseases unsuitable for the trial
- HIV infection
- Any conditions that may increase patient risk or interfere with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, PhD
CONTACT
Y
Yongxian Hu, PhD
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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