EBV Associated Lymphoid NeoplasmsNCT07525024
KSD-101 in Patients With EBV-associated Hematological Malignancies
An observational study of EBV Associated Lymphoid Neoplasms, run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- EBV Associated Lymphoid Neoplasms
- What is being tested?
- Autologous dendritic cell vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, Hainan
Wei-Li Zhao, 0898-62629196, zwl_trial@163.com
About this study
Official title: 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
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
- EBV Associated Lymphoid Neoplasms
- Being tested
- Autologous dendritic cell vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dendritic cell vaccineBiological
Subcutaneous injection, once every 2 weeks for 3-5 doses.
| Study group | Role | What they receive |
|---|---|---|
| KSD-101 therapy | Not described Receives: Biological: Autologous dendritic cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
The proportion of patients with complete and partial response after treatment.
Measured: Baseline up to 24 months after DC vaccines injection.
Secondary outcomes (7)
Complete Response Rate
The proportion of patients with complete response after treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to study completion (up to 24 months)
Changes of EBV DNA load, lymphocytes and cytokines
Measured: From enrollment to study completion (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV Associated Lymphoid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525024
- Sponsor's protocol ID
- KSD-101-RW102
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07525024
- Acronym / sponsor ID
- KSD-101-RW102
- Conditions
- EBV Associated Lymphoid Neoplasms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KSD-101 therapy | – | Biological: Autologous dendritic cell vaccine |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous dendritic cell vaccineSubcutaneous injection, once every 2 weeks for 3-5 doses. | Biological | KSD-101 therapy |
Primary outcome
Overall Response Rate
Time frame: Baseline up to 24 months after DC vaccines injection.
The proportion of patients with complete and partial response after treatment.
7 secondary outcomes
Complete Response Rate
Time frame: Baseline up to 24 months after DC vaccines injection.
Disease Control Rate
Time frame: Baseline up to 24 months after DC vaccines injection.
Duration of Response
Time frame: From enrollment to study completion (up to approximately 24 months)
Progression-free survival
Time frame: Baseline up to data cut-off (up to 24 months)
Overall survival rate
Time frame: Baseline up to data cut-off (up to 24 months)
Treatment-Related Adverse Events rate as assessed by 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EBV Associated Lymphoid Neoplasms, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Baseline up to 24 months after DC vaccines injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.