Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia

Exclusion Criteria

• •Complicated with other diseases that are not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, poorly controlled pulmonary diseases or mental disorders.
• •Having other active malignant tumors.
• •Complicated with severe infections that cannot be effectively controlled.
• •Those who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), and those with peripheral blood hepatitis B virus (HBV) DNA higher than the detection limit need to be excluded; those who are positive for hepatitis C virus (HCV) antibody and positive for peripheral blood HCV RNA need to be excluded; those with positive cytomegalovirus (CMV) DNA detection; those with positive peripheral blood Epstein-Barr virus (EBV) DNA detection.
• •Those who are positive for human immunodeficiency virus (HIV) antibody test or positive for syphilis test.
• •Having a history of severe allergy to biological products (including antibiotics).
• •Patients with relapsed after allogeneic hematopoietic stem cell transplantation who have experienced grade 3 - 4 acute graft-versus-host disease (GvHD).
• •Female subjects who are pregnant or in the lactation period.
• •Active autoimmune diseases that require systemic immunosuppressive treatment.
• •Situations that the investigator believes may increase the risk of the subject or interfere with the test results.