LeukemiaEarly Phase 1NCT06890494
Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia
A Early Phase 1 study testing BiTE-EV in people with Leukemia, run by Beijing GoBroad Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leukemia
- What is being tested?
- BiTE-EV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Safety and Efficacy of BiTE-EV Therapy in Relapsed/Refractory Acute B-Cell Lymphoblastic Leukemia
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
- Being tested
- BiTE-EV
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiTE-EVDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BiTE-EV therapy | Experimental | Not described Receives: Drug: BiTE-EV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 3 months
Secondary outcomes (5)
the efficacy of BiTE-EV in the treatment of relapsed/refractory acute B-cell lymphoblastic leukemia.
Outcome Measure 1: Treatment response assessed at the end of the first and second treatment cycles. Assessment: Complete Remission (CR)，CR with incomplete hematologic recovery (CRi)，Partial Remission (PR)，No Response (NR)，Stable Disease (SD)，Progressive Disease (PD)，Unit of Measure: Categorical (CR, CRi, PR, NR, SD, PD) Outcome Measure 2: Quantitative assessment of MRD clearance in fusion gene-positive leukemia patients.Assessment: MRD Level，Unit of Measure: e.g., log10 reduction, MRD positive/negative, or % MRD (specify actual unit) Outcome Measure 3: Duration of response in patients who complete treatment without further anti-leukemic therapy.Assessment: Time from initial response to relapse or progression.Unit of Measure: Months Outcome Measure 4: Leukemia-free survival in patients who complete treatment without further anti-leukemic therapy.Assessment: Time from initial response to relapse or death from leukemia-related causes.Unit of Measure: Months
Measured: 2 years
Maximum Concentration (Cmax)
The maximum concentration of BiTE-EV accumulated in peripheral blood during infusion.
Assessment: Maximum concentration Unit of Measure: ng/mL
Measured: 2 months
Time to Maximum Concentration (Tmax)
The time to reach the maximum concentration of BiTE-EV in peripheral blood during infusion.
Assessment: Time to maximum concentration Unit of Measure: hours (h)
Measured: 2 months
Half-life (t½)
The half-life of BiTE-EV in peripheral blood. Assessment: Half-life Unit of Measure: hours (h)
Measured: 2 months
Area Under the Curve (AUC28d)
The 28-day area under the plasma concentration versus time curve for BiTE-EV. Assessment: Area under the curve from time 0 to 28 days. Unit of Measure: ng*h/mL
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start18 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890494
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2024-054
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of BiTE-EV Therapy in Relapsed/Refractory Acute B-Cell Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06890494
- Acronym / sponsor ID
- BJGBYY-IIT-LCYJ-2024-054
- Conditions
- Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BiTE-EV therapy | Experimental | Drug: BiTE-EV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiTE-EVThi 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. | Drug | BiTE-EV therapy |
Primary outcome
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: 3 months
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
Severity of Treatment-Related Adverse Events
Time frame: 3 months
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)
Frequency of Treatment-Related Adverse Events
Time frame: 3 months
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
Type of Treatment-Related Adverse Events
Time frame: 3 months
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)
5 secondary outcomes
the efficacy of BiTE-EV in the treatment of relapsed/refractory acute B-cell lymphoblastic leukemia.
Time frame: 2 years
Maximum Concentration (Cmax)
Time frame: 2 months
Time to Maximum Concentration (Tmax)
Time frame: 2 months
Half-life (t½)
Time frame: 2 months
Area Under the Curve (AUC28d)
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BiTE-EV in people with Leukemia, run by Beijing GoBroad Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Pan (8618911067969, panj@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events (TRAEs) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.