Clinical Study on the Safety and Efficacy of BiTE-EV Therapy in Relapsed/Refractory Acute B-Cell Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Related Adverse Events (TRAEs)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
BiTE-EV therapy
干预措施: BiTE-EV (Drug)
结局指标
主要结局
Incidence of Treatment-Related Adverse Events (TRAEs)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
Jing Pan
Director of Dept of Hemato-Oncology and Immunotherapy
Beijing GoBroad Hospital