Study on the Efficacy and Safety of Autocrine p40 Chimeric Antigen Receptor T Cells Targeting CD19 and CD20 (CD19CD20-CAR.p40-T) in Refractory B-Cell Lymphoma
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.
• 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.