Clinical Study on the Safety and Efficacy of BiTE-EV Therapy in Relapsed/Refractory Acute B-Cell Lymphoblastic Leukemia
The goal of this clinical trial is to learn if BiTE-EV works to treat relapsed/refractory acute B-cell leukemia in adults. It will also learn about the safety of BiTE-EV. The main questions it aims to answer are: Can BiTE-EV effectively treat relapsed/refractory acute B-cell lymphoblastic leukemia? What medical problems do participants have when taking BiTE-EV? Participants will: Take BiTE-EV every other day for 1 or 2 months Keep a diary of their symptoms during the medication period During the follow-up period, visit the clinic once every 4 weeks for checkups and tests
• Patients with acute B lymphocytic leukemia who are clinically diagnosed as relapsed (relapsed after CAR-T treatment or relapsed after transplantation), refractory, or whose T cells cannot be used for the production of CAR-T cells.
• Tumor cells show positive expression of CD19 detected by flow cytometry or immunohistochemistry.
• The age is between 18 and 70 years old (inclusive).
• The expected survival period from the date of signing the informed consent form is greater than 3 months.
• The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤ 2.
• The functions of vital organs should meet the following requirements:
‣ The ejection fraction (EF) is \> 50%, and there is no significant abnormality in the electrocardiogram.
⁃ The peripheral oxygen saturation (SpO2) is ≥ 92%.
⁃ The serum creatinine (Cr) is ≤ 1.5 times the upper limit of normal (ULN).
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 5 times the upper limit of normal (ULN), and total bilirubin (TBil) is ≤ 3 times the upper limit of normal (ULN).
• Subjects with pregnancy plans must agree to take contraceptive measures before enrolling in the study and six months after the study. If the subject is pregnant or suspected to be pregnant, they should immediately notify the investigator.
• The subject or the guardian understands and signs the informed consent form.