Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma

About this study

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.

Condition: Relapsed/Refractory B-cell Lymphoma
Tested: CAR-T cell
Sponsor: Shenzhen University General Hospital

Who can join

Age: 18 to 75 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 15

Minimum age: 18 years
Maximum age: 75 years
Study condition: Relapsed/Refractory B-cell Lymphoma
Aged between 15 and 75 years old, regardless of gender;
Diagnosed with relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Expected survival time of ≥ 3 months;
Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry;
Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
No severe heart, lung, liver, or kidney diseases;
Capable of understanding and willing to sign the informed consent form for this trial;
No contraindications to peripheral blood apheresis for the subject;
Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;
The subject must have received standard first- and second-line treatment regimens;
Not having received antibody-based drug treatment within 2 weeks before cell therapy.

Exclusion 17

History of allergy to any component in the cell product;
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;
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;
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;
Abnormal lung function with oxygen saturation \< 92% under room air;
Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;
Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;
History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;
Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;
Presence of uncontrolled active infection;
Previous use of any CAR-T cell product or other genetically modified T cell therapies;
Vaccination with live vaccines within 4 weeks before enrollment;
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;
History of alcohol abuse, drug abuse, or mental illness in the subject;
The subject participated in any other clinical study within 3 months before joining this clinical study;
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;
Other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study.

Where

1 site, 1 recruiting

Shenzhen University General Hospital

Shenzhen, Other (Non U.s.), China

Recruiting

Contact

lixin wang

0755-21839999 wanglixin1991@sohu.com