Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

The Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.

Inclusion Criteria:

• Histological detection confirmed CD19/CD22 postive lymphoma;
• Recieved more than 2 lines of chemotherapy;
• Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
• Life expectation for more than 3 months;
• ECOG ≥ 2;
• Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%;
• CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
• Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
• With measurable disease;
• Written informed consent could be acquired;

Exclusion Criteria:

• Immunosuppressive agents or steroids in recent 1 week before recruitment;
• Uncontrolled infection;
• HIV positive ;
• Active HBV or HCV infection;
• Women in pregnancy and lactation;
• Refuse to conception control during treatment and 1 year after CAR-T infusion;
• Uncured malignancies other than non-Hodgkin lymphoma;
• Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
• Inheritated immune deficiancy;
• Severe heart disease.