Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma
NCT ID: NCT07097207
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2023-10-01
2026-09-30
Brief Summary
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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.
Detailed Description
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* Primary Endpoint\*\*: To assess treatment-emergent adverse events (TEAEs) within 30 days after intravenous infusion of CAR-T cells.
* Secondary Endpoints\*\*:
* Objective response rate (ORR=CR+PR) within 8 weeks;
* Overall survival (OS) and progression-free survival (PFS) at 6 months;
* In vivo expansion and persistence kinetics of CAR-T cells.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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CART group
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
CAR-T cell
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Interventions
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CAR-T cell
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
4. Expected survival time of ≥ 3 months;
5. Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry;
6. Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
7. No severe heart, lung, liver, or kidney diseases;
8. Capable of understanding and willing to sign the informed consent form for this trial;
9. No contraindications to peripheral blood apheresis for the subject;
10. Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;
11. The subject must have received standard first- and second-line treatment regimens;
12. Not having received antibody-based drug treatment within 2 weeks before cell therapy.
Exclusion Criteria
2. The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹/L, absolute neutrophil count (ANC) ≤ 0.5×10⁹/L, absolute lymphocyte count (ALC) ≤ 0.5×10⁹/L, platelet count (PLT) ≤ 25×10⁹/L;
3. The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg/dl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg/dl;
4. Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) \< 50% as detected by echocardiography;
5. Abnormal lung function with oxygen saturation \< 92% under room air;
6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;
7. Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;
8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;
9. Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;
10. Presence of uncontrolled active infection;
11. Previous use of any CAR-T cell product or other genetically modified T cell therapies;
12. Vaccination with live vaccines within 4 weeks before enrollment;
13. Subjects positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum particle agglutination assay (TPPA)/rapid plasma reagin (RPR), as well as HBV carriers;
14. History of alcohol abuse, drug abuse, or mental illness in the subject;
15. The subject participated in any other clinical study within 3 months before joining this clinical study;
16. Female subjects with any of the following conditions: a) Currently pregnant or breastfeeding; or b) Having a pregnancy plan during the trial period; or c) Being fertile but unable to take effective contraceptive measures;
17. Other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study.
18 Years
75 Years
ALL
No
Sponsors
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Shenzhen University General Hospital
OTHER
Responsible Party
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Principal Investigators
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Lixin Wang, PHD
Role: PRINCIPAL_INVESTIGATOR
Shenzhen University General Hospital
Locations
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Shenzhen University General Hospital
Shenzhen, Other (Non U.s.), China
Countries
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Central Contacts
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Facility Contacts
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chuling fang
Role: primary
Other Identifiers
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111
Identifier Type: OTHER
Identifier Source: secondary_id
111
Identifier Type: -
Identifier Source: org_study_id