OncoMatch/Clinical Trials/NCT06890494
Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia
Is NCT06890494 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies BiTE-EV for leukemia.
Treatment: BiTE-EV — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive expression
Tumor cells show positive expression of CD19 detected by flow cytometry or immunohistochemistry.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
serum creatinine ≤ 1.5x ULN
Liver function
ALT and AST ≤ 5x ULN, total bilirubin ≤ 3x ULN
Cardiac function
ejection fraction (EF) > 50%, no significant abnormality in the electrocardiogram
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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