Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
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.
‣ Subjects must meet all of the following criteria to be enrolled:
• Aged 18 to 75 years, regardless of sex;
• Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;
• ECOG performance status of 0-2;
• Expected survival of at least 3 months;
• CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
• Patients who are resistant/refractory to CD19 CAR-T cell therapy or have low CD19 expression;
• No severe cardiac, pulmonary, hepatic, or renal disease;
• Able to understand and willing to sign the informed consent form for this study;
• No contraindications to peripheral blood mononuclear cell collection/apheresis;
⁃ At least one measurable and evaluable lesion according to RECIST 1.1;
⁃ Must have previously received standard first-line and second-line therapy;