Actively Recruiting
Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-07
52
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma
CONDITIONS
Official Title
Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old, no gender limit
- Diagnosed with 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 after specified prior treatments depending on lymphoma type
- Previous treatment includes CD20 monoclonal antibody therapy (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 biopsy positive for CD19 expression
- ECOG performance status score 0-2
- Adequate organ function including liver enzymes ≤ 2.5x upper limit normal, creatinine clearance ≥ 60 mL/min, total bilirubin and alkaline phosphatase ≤ 1.5x upper limit normal, glomerular filtration rate > 50 mL/min, cardiac ejection fraction ≥ 50%, and oxygen saturation > 92% in room air
- Previous stem cell transplantation allowed
- Completed approved anti-B-cell lymphoma treatments at least 3 weeks prior
- Previous 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 and swine flu virus
You will not qualify if you...
- Allergy to any components of the cell therapy products
- History of other tumors
- Acute graft-versus-host disease or extensive chronic GVHD grade II-IV or ongoing anti-GVHD treatment
- Gene therapy received within past 3 months
- Active infections requiring treatment except simple urinary tract infections or bacterial pharyngitis
- Infections with hepatitis B (HBsAg positive, except low HBV-DNA), hepatitis C, syphilis, HIV, or other immunodeficiency diseases
- Grade III or IV cardiac dysfunction per NYHA criteria
- Unresolved toxicity from prior antitumor therapy greater than grade 1 except fatigue, anorexia, alopecia
- History of epilepsy or other central nervous system disorders
- Evidence of central nervous system lymphoma on brain CT or MRI
- Lactating women unwilling to stop breastfeeding
- Any other factors increasing risk or interfering with study results as judged by investigator
AI-Screening
AI-Powered Screening
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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, Professor
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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