Clinical trial · Observational
KSD-101 in Patients With EBV-associated Hematological Malignancies
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV Associated Lymphoid Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous dendritic cell vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- KSD-101 therapy
- interventionNames
- Biological: Autologous dendritic cell vaccine
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Baseline up to 24 months after DC vaccines injection.
- description
- The proportion of patients with complete and partial response after treatment.
Secondary outcomes (7)
- measure
- Complete Response Rate
- timeFrame
- Baseline up to 24 months after DC vaccines injection.
- description
- The proportion of patients with complete response after treatment.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with EBV-associated hematological malignancies who receive KSD-101 Vaccine Therapy (non-genetically modified) . 1. Patients aged 12 years or older on the date of signing the informed consent form. 2. 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available