Clinical trial NCT06890494: Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia
Official title: Clinical Study on the Safety and Efficacy of BiTE-EV Therapy in Relapsed/Refractory Acute B-Cell Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Leukemia
Lead sponsor: Beijing GoBroad Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Exclusion Criteria:If any one of the following conditions is met, the subject cannot be enrolled in the group:

* 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.

Primary outcomes:
measure: Incidence of Treatment-Related Adverse Events (TRAEs)
timeFrame: 3 months
measure: Severity of Treatment-Related Adverse Events
timeFrame: 3 months
measure: Frequency of Treatment-Related Adverse Events
timeFrame: 3 months
measure: Type of Treatment-Related Adverse Events
timeFrame: 3 months
Secondary outcomes:
measure: the efficacy of BiTE-EV in the treatment of relapsed/refractory acute B-cell lymphoblastic leukemia.
timeFrame: 2 years
measure: Maximum Concentration (Cmax)
timeFrame: 2 months
measure: Time to Maximum Concentration (Tmax)
timeFrame: 2 months
measure: Half-life (t½)
timeFrame: 2 months
measure: Area Under the Curve (AUC28d)
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Hospital
Study officials:
References: