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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSD-101 therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cell vaccine | Biological | Subcutaneous injection, once every 2 weeks for 3-5 doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The proportion of patients with complete and partial response after treatment. | Baseline up to 24 months after DC vaccines injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | The proportion of patients with complete response after treatment. | 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. |
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Inclusion Criteria:
Patients with EBV-associated hematological malignancies who receive KSD-101 Vaccine Therapy (non-genetically modified) .
The participant and/or their legal guardian voluntarily agrees to participate and has signed the informed consent form.
Exclusion Criteria:
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Ruijin-Hainan Hospital,Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin-Hainan Hospital,Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital) | Qionghai | Hainan | China |
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| 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. | 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. | 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. | 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. | 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) |