CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma: A Prospective, Single-Arm, Single-Center, Phase 2 Trial
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.
• 14 years to 85 years, expected survival \> 3 months;
• CD19 positive with or without CD22 positive Large B-cell lymphoma;
• relapsed or refractory disease;
• ECOG-PS score=0-2;
• Having at least one measurable lesion;
• Cardiac function: 1-2 levels;
• Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
• kidney: Cr≤1.25ULN;
• bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
• No serious allergic constitution;
• No other serious diseases that conflicts with the clinical program;
• No other cancer history;
• No serious mental disorder;
• Informed consent is signed by a subject or his lineal relation.