KSD-101 in Patients With EBV-associated Hematological Malignancies
ConditionEBV Associated Lymphoid Neoplasms
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Autologous dendritic cell vaccine
Biological/VaccineSubcutaneous injection, once every 2 weeks for 3-5 doses.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: KSD-101 therapy1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
Complete Response Rate
The proportion of patients with complete response after treatment.
Time frame
Baseline up to 24 months after DC vaccines injection.2
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.3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: