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Not yet recruiting NCT07525024

KSD-101 in Patients With EBV-associated Hematological Malignancies

— Observational EBV Associated Lymphoid Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous dendritic cell vaccine.
Who it may be relevant to
Registry conditions: EBV Associated Lymphoid Neoplasms. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Biological Autologous dendritic cell vaccine
    Subcutaneous injection, once every 2 weeks for 3-5 doses.

Primary outcome measures

  • Overall Response Rate [Time frame: Baseline up to 24 months after DC vaccines injection.]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Resea — Qionghai

Identifiers

NCT: NCT07525024 · KSD-101-RW102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗