NCT06890494 Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia

Trial Parameters

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Brief Summary

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

Eligibility Criteria

Inclusion Criteria: Patients can be enrolled in the group only if they meet all of the following conditions: * 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

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