Actively Recruiting
Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma
Led by Shenzhen University General Hospital · Updated on 2025-07-31
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
1. Study Title: A Study on the Efficacy and Safety of Autocrine p40 CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19/CD20-CAR.p40-T) in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: * Primary Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. * Secondary Objective: To evaluate the efficacy of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. 3. Participant Intervention: * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
CONDITIONS
Official Title
Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 15 and 75 years old, regardless of gender
- Diagnosed with relapsed or refractory B-cell lymphoma based on 2020 WHO criteria
- ECOG performance status score of 0 to 2
- Expected survival time of 3 months or more
- Tumor cells confirmed to express CD20 by flow cytometry or immunohistochemistry
- Tolerant to CD19 CAR-T therapy or have low CD19 expression
- No severe heart, lung, liver, or kidney diseases
- Able to understand and willing to sign the informed consent form
- No contraindications to peripheral blood apheresis
- Have clearly measurable and evaluable lesions according to RECIST 1.1 criteria
- Received standard first- and second-line treatment regimens
- No antibody-based drug treatment within 2 weeks before cell therapy
You will not qualify if you...
- History of allergy to any component of the cell product
- Blood routine exam showing WBC ≤ 1×10⁹/L, ANC ≤ 0.5×10⁹/L, ALC ≤ 0.5×10⁹/L, or platelet count ≤ 25×10⁹/L
- Lab tests with total serum bilirubin ≥ 1.5 mg/dL, ALT or AST over 2.5 times the upper limit, or serum creatinine ≥ 2.0 mg/dL
- Heart failure grade III or IV by NYHA or left ventricular ejection fraction below 50%
- Lung function with oxygen saturation below 92% on room air
- Recent (within 12 months) severe heart conditions like myocardial infarction, angioplasty, or unstable angina
- Grade 3 hypertension poorly controlled by medication
- History of serious brain injury, unconsciousness, epilepsy, severe cerebral ischemia, or brain hemorrhage
- Autoimmune disease, immunodeficiency, or needing immunosuppressive treatments
- Uncontrolled active infection
- Previous use of any CAR-T or genetically modified T cell therapies
- Live vaccine within 4 weeks before enrollment
- Positive for HIV, hepatitis B or C, or syphilis, including HBV carriers
- History of alcohol abuse, drug abuse, or mental illness
- Participation in another clinical study within 3 months
- Female subjects currently pregnant, breastfeeding, planning pregnancy during the trial, or unable to use effective contraception
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen University General Hospital
Shenzhen, Other (Non U.s.), China, 518055
Actively Recruiting
Research Team
L
lixin wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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