Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia
ConditionLeukemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing GoBroad Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
BiTE-EV
DrugThi 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.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: BiTE-EV therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
3 months2
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)
Time frame
3 months3
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
Time frame
3 months4
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)
Time frame
3 monthsSecondary outcomes
1
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
Time frame
2 years2
Maximum Concentration (Cmax)
The maximum concentration of BiTE-EV accumulated in peripheral blood during infusion. Assessment: Maximum concentration Unit of Measure: ng/mL
Time frame
2 months3
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)
Time frame
2 months4
Half-life (t½)
The half-life of BiTE-EV in peripheral blood. Assessment: Half-life Unit of Measure: hours (h)
Time frame
2 monthsSponsors and contacts
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Source ClinicalTrials.gov