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 (Jun 2026). This Early Phase 1 trial studies BiTE-EV for leukemia.

Early Phase 1RecruitingBeijing GoBroad HospitalNCT06890494Data as of Jun 2026Location: China

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

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Extracted eligibility criteria

Treatments studied

Other

BiTE-EV

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)

Demographics

Ages ≤ 70

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.

Frequently asked questions

Is NCT06890494 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require CD19?

Yes, CD19 positive expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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