CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors

Inclusion Criteria12

• CD 19 + / CD 22 + B cell hematological tumor was confirmed by pathological and histological examination, and the patient met the following criteria for relapsed or refractory B cell hematological tumor:
• Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can be met):
• i . Recurrence within 6 months of first remission; ii. Primary refractory without complete remission after 2 cycles of standard chemotherapy regimen; iii. No complete remission or recurrence after first-line or multiline salvage chemotherapy; iv. Not eligible for HSCT conditions, abandonment of HSCT, or relapse after HSCT due to conditional limitations.
• Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4 items plus item 5):
• i . After four courses of chemotherapy with a standard regimen, tumor shrinkage was less than 50% or disease progression; ii . CR after standard regimen chemotherapy, but relapsed within 6 months; iii.2 or more recurrences after CR; iv . Not suitable for hematopoietic stem cell transplantation, or abandoning HSCT due to conditional restrictions or relapse after hematopoietic stem cell transplantation; v . Subject must have received prior adequate treatment, including at least: a monoclonal antibody against CD 20 and combination chemotherapy containing an anthracycline drug agent.
• The results of FCM or immunohistochemical detection of tumor antigen (CD 19 / CD 22) were positive.
• The estimated survival period is more than 3 months starting from the signing of the informed consent form.
• Good organ function,Meet the following requirements：
• HGB≥70g/L(transfusible)
• Liver and kidney function: creatinine ≤1.5XULN: total bilirubin ≤1.5XULN:ALT and AST≤2.5X ULN
• Cardiopulmonary function: left ventricular ejection fraction \>50%; Blood oxygen saturation \>90%;
• Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.