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

NCT ID: NCT06890494

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-18
• Study Completion Date: 2026-12-31

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

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BiTE-EV therapy

Group Type: EXPERIMENTAL

BiTE-EV

Intervention Type: DRUG

Thi product organically combines extracellular vesicles with BiTEs, and enables stable expression of the bispecific antibody on the surface of mesenchymal stem cells. By collecting the culture supernatant, the bispecific vesicles BiTE-EV, which express both CD3 and CD19 antibodies on their surface, are enriched and isolated.

Interventions

BiTE-EV

Thi product organically combines extracellular vesicles with BiTEs, and enables stable expression of the bispecific antibody on the surface of mesenchymal stem cells. By collecting the culture supernatant, the bispecific vesicles BiTE-EV, which express both CD3 and CD19 antibodies on their surface, are enriched and isolated.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing GoBroad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing Pan

Director of Dept of Hemato-Oncology and Immunotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing GoBroad Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Pan

Role: CONTACT

panj@gobroadhealthcare.com

8618911067969

Other Identifiers

BJGBYY-IIT-LCYJ-2024-054

Identifier Type: -

Identifier Source: org_study_id