Actively Recruiting
Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
Led by Shenzhen University General Hospital · Updated on 2026-04-02
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 CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: Primary Objective: To evaluate the safety of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Secondary Objective: To evaluate the efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Exploratory Objective: To assess in vivo expansion and persistence of infused CD19/CD20 CAR/TRuC-T cells. 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/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
CONDITIONS
Official Title
Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, regardless of sex
- Histologically confirmed relapsed/refractory B-cell lymphoma per 2020 WHO classification
- ECOG performance status of 0-2
- Expected survival of at least 3 months
- CD20 expression on tumor cells confirmed by flow cytometry or immunohistochemistry
- Resistant or refractory to CD19 CAR-T therapy or low CD19 expression
- No severe cardiac, lung, liver, or kidney disease
- Able to understand and willing to sign informed consent
- No contraindications to blood cell collection or apheresis
- At least one measurable lesion per RECIST 1.1
- Previously received standard first-line and second-line therapy
- No antibody-based therapy within 2 weeks before cell therapy
You will not qualify if you...
- Allergy to any component of the cell product
- Abnormal blood counts: WBC ≤1 x 10⁹/L, ANC ≤0.5 x 10⁹/L, ALC ≤0.5 x 10⁹/L, or platelets ≤25 x 10⁹/L
- Lab abnormalities: total bilirubin ≥1.5 mg/dL; ALT or AST >2.5 times normal; creatinine ≥2.0 mg/dL
- Severe heart failure (NYHA Class III or IV) or LVEF below 50%
- Low oxygen saturation (<92%) on room air
- Recent serious heart conditions within 12 months
- Poorly controlled grade 3 hypertension despite medication
- History of brain trauma, seizures, or severe brain blood flow problems
- Autoimmune disease, immune deficiency, or need for immunosuppressive therapy
- Uncontrolled active infections
- Prior CAR-T or other genetically modified T-cell therapies
- Live vaccine received within 4 weeks before enrollment
- Positive for HIV, HBV, HCV, or syphilis tests or HBV carrier
- History of alcohol or drug abuse, or psychiatric illness
- Participation in another clinical trial within 3 months
- For female participants: currently pregnant, breastfeeding, planning pregnancy, or unwilling/unable to use effective contraception
- Any condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen University General Hospital
Shenzhen, Guangdong, China, 518055
Actively Recruiting
Research Team
L
LIXIN LI, PHD
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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