A Prospective, Single-arm, Observational Real-world Clinical Practice Study on the Efficacy and Safety of Dendritic Cell-based Vaccines (KSD-101) in Patients With EBV-associated Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
Epstein-Barr virus (EBV) is a double-stranded DNA virus belonging to the Gammaherpesvirinae subfamily of Herpesviridae. It primarily infects B cells and pharyngeal epithelial cells, and can also infect NK cells and T cells. EBV is closely associated with a variety of hematological malignancies, including EBV-positive diffuse large B-cell lymphoma (EBV+DLBCL), NK/T-cell lymphoma (NKTCL), Hodgkin lymphoma (HL), Burkitt lymphoma (BL), EBV-positive nodal T-follicular helper cell lymphoma, angioimmunoblastic type (EBV+nTFHL-AI), and primary cutaneous T-cell lymphoma (CTCL). EBV-positive hematological malignancies are characterized by poor prognosis and limited therapeutic options, and there are currently no approved EBV-specific therapies. KSD-101 is a novel dendritic cell vaccine loaded with EBV-associated tumor-like composite antigens, which possesses strong antigen-presenting capacity and can initiate EBV-specific T-cell immunity. This study aims to investigate the real-world clinical efficacy and safety of KSD-101, providing an important reference for optimizing its clinical application, as well as theoretical support for the further development of novel therapeutic strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with EBV-associated hematological malignancies who receive KSD-101 Vaccine Therapy (non-genetically modified) .
- •Patients aged 12 years or older on the date of signing the informed consent form.
- •Patients with a confirmed diagnosis of EBV-associated hematological malignancies who either: have failed standard treatment; or have voluntarily chosen KSD-101 as prophylactic / anti-relapse therapy by the patient and/or their legal guardian.
- •The participant and/or their legal guardian voluntarily agrees to participate and has signed the informed consent form.
排除标准
- •Female patients who are pregnant (positive urine or serum pregnancy test), breastfeeding, or male/female patients planning to conceive within 1 year after enrollment.
- •Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the upper limit of normal; patients positive for anti-HCV antibody and peripheral blood HCV RNA; patients positive for anti-HIV antibody; or patients positive for syphilis-specific antibody.
- •Patients with central nervous system (CNS) involvement (e.g., cerebral edema requiring steroid intervention, or progressive brain metastasis).
- •Patients with uncontrolled infectious disease within 4 weeks prior to screening.
- •Patients with severe underlying diseases, including cardiovascular disease, respiratory disease, renal insufficiency, coagulation disorders, autoimmune disease, or immunodeficiency disease.
- •Patients who have received prophylactic live or attenuated live vaccines within 4 weeks prior to screening.
- •Patients who have participated in other clinical studies within 4 weeks prior to screening.
- •Patients with a history of severe drug allergy or penicillin allergy.
- •Patients with a history of drug abuse or addiction.
- •Any other conditions deemed inappropriate for study enrollment by the investigator team.
研究组 & 干预措施
KSD-101 therapy
干预措施: Autologous dendritic cell vaccine (Biological)
结局指标
主要结局
Overall Response Rate
时间窗: Baseline up to 24 months after DC vaccines injection.
The proportion of patients with complete and partial response after treatment.
次要结局
- Complete Response Rate(Baseline up to 24 months after DC vaccines injection.)
- Disease Control Rate(Baseline up to 24 months after DC vaccines injection.)
- Duration of Response(From enrollment to study completion (up to approximately 24 months))
- Progression-free survival(Baseline up to data cut-off (up to 24 months))
- Overall survival rate(Baseline up to data cut-off (up to 24 months))
- Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0(From enrollment to study completion (up to 24 months))
- Changes of EBV DNA load, lymphocytes and cytokines(From enrollment to study completion (up to 24 months))
研究者
Zhao Weili
Professor and Director, Shanghai Institute of Hematology
Ruijin Hospital