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.
Study Type
OBSERVATIONAL
Enrollment
80
Subcutaneous injection, once every 2 weeks for 3-5 doses.
Ruijin-Hainan Hospital,Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, Hainan, China
Overall Response Rate
The proportion of patients with complete and partial response after treatment.
Time frame: Baseline up to 24 months after DC vaccines injection.
Complete Response Rate
The proportion of patients with complete response after treatment.
Time frame: Baseline up to 24 months after DC vaccines injection.
Disease Control Rate
The proportion of patients with complete response, partial response, and stable disease after treatment.
Time frame: Baseline up to 24 months after DC vaccines injection.
Duration of Response
Duration of response is defined as the period from the first response (at least PR) to first occurrence of disease progression or relapse, or death from any cause, whichever occurred first.
Time frame: From enrollment to study completion (up to approximately 24 months)
Progression-free survival
Progression-free survival is defined as the time from enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to 24 months)
Overall survival rate
Overall survival is defined as the time from enrollment to death from any cause.
Time frame: Baseline up to data cut-off (up to 24 months)
Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Time frame: From enrollment to study completion (up to 24 months)
Changes of EBV DNA load, lymphocytes and cytokines
Time frame: From enrollment to study completion (up to 24 months)
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