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

NCT06890494 | Recruiting Early Phase 1

• 1 other identifier: BJGBYY-IIT-LCYJ-2024-054
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment-Related Adverse Events (TRAEs)

  The number of participants experiencing treatment-related adverse events during the study. Assessment: Number of participants with at least one TRAE. Unit of Measure: Number of participants

  3 months

• Severity of Treatment-Related Adverse Events

  The severity of TRAEs, graded according to CTCAE version X. Assessment: Maximum CTCAE grade for each TRAE per participant. Unit of Measure: CTCAE grade (1, 2, 3, 4, or 5)

  3 months

• Frequency of Treatment-Related Adverse Events

  The number of occurrences of each specific TRAE during the study. Assessment: Number of events for each specific TRAE. Unit of Measure: Number of events

  3 months

• Type of Treatment-Related Adverse Events

  The specific types of TRAEs observed during the study. Assessment: List of all TRAEs observed, classified by system organ class and preferred term according to MedDRA (or other standard medical dictionary). Unit of Measure: Categorical (System Organ Class and Preferred Term)

  3 months

Secondary Outcomes (5)

• the efficacy of BiTE-EV in the treatment of relapsed/refractory acute B-cell lymphoblastic leukemia.

  2 years

• Maximum Concentration (Cmax)

  2 months

• Time to Maximum Concentration (Tmax)

  2 months

• Half-life (t½)

  2 months

• Area Under the Curve (AUC28d)

  28 days

Study Arms (1)

BiTE-EV therapy

EXPERIMENTAL

Drug: BiTE-EV

Interventions

BiTE-EV 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.

BiTE-EV therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jing Pan

CONTACT

8618911067969; panj@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dept of Hemato-Oncology and Immunotherapy

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 24, 2025
• Study Start: January 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CN (1)