CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors

Inclusion Criteria:

• Fully understand and voluntarily sign the informed consent form, and be willing andable to comply with the visit, treatment protocol, laboratory tests, and other studyrequirements specified in the flow sheet;

• CD 19 + / CD 20 + B cell hematological tumor was confirmed by pathological andhistological examination, and the patient met the following criteria for relapsed orrefractory B cell hematological tumor:

1. Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can bemet):i . Recurrence within 6 months of first remission; ii. Primary refractorywithout complete remission after 2 cycles of standard chemotherapy regimen;iii. No complete remission or recurrence after first-line or multiline salvagechemotherapy; iv. Not eligible for HSCT conditions, abandonment of HSCT, orrelapse after HSCT due to conditional limitations.

2. Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4items 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.

• B-cell hematological tumors include the following 3 categories:

1. B-cell acute lymphoblastic leukemia (B-ALL);

2. Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL);

3. Invasive B-cell lymphoma (DLBCL, BL, and MCL);

• With measurable or evaluable lesions: Lymphoma patients require a single lesion 15mmor 2 or more lesions 10mm; patients with leukemia require persistent positive orpositive recurrence of bone marrow MRD.

• Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to

• The results of FCM or immunohistochemical detection of tumor antigen (CD 19 / CD 20)were positive.

• The estimated survival period is more than 3 months starting from the signing of theinformed consent form.

Exclusion Criteria:

• Appearance of one of the following cardiac criteria: atrial fibrillation; myocardialinfarction in the last 12 months; prolonged QT syndrome or secondary QT extension,as judged by the investigator. Echocardiography LVSF <30% or LVEF <50%; clinicallysignificant pericardial effusion; cardiac insufficiency NYHA (New York HeartAssociation) III or IV (confirmed by echocardiography within 12 months oftreatment).

• Active GVHD.

• History of severe pulmonary function impairment disease.

• Other malignant tumors in the advanced stage.

• Severe infection or persistent infection that cannot be effectively controlled.

• Combined with severe autoimmune disease or innate immune deficiency.

• Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA 500 IU / ml andabnormal liver function] or hepatitis C antibody [HCV-Ab] positive, HCV-RNA abovethe lower limit of detection of the analytical method and abnormal liver function).

• Human immunodeficiency virus (HIV) infection or syphilis infection.

• History of severe allergies to biological products (including antibiotics).

• There are central nervous system disorders, such as uncontrolled epilepsy,cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, etc..

• Female patients are in pregnancy and lactation, or have a pregnancy plan within 12months.

• situations where the investigator may increase the risk or interfere with the testresults.