KSD-101 in Patients With EBV-associated Hematological Malignancies

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Overall Response Rate [Срок оценки: Baseline up to 24 months after DC vaccines injection.]

Вторичные конечные точки (7)

• Complete Response Rate [Срок оценки: Baseline up to 24 months after DC vaccines injection.]
• Disease Control Rate [Срок оценки: Baseline up to 24 months after DC vaccines injection.]
• Duration of Response [Срок оценки: From enrollment to study completion (up to approximately 24 months)]
• Progression-free survival [Срок оценки: Baseline up to data cut-off (up to 24 months)]
• Overall survival rate [Срок оценки: Baseline up to data cut-off (up to 24 months)]
• Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0 [Срок оценки: From enrollment to study completion (up to 24 months)]
• Changes of EBV DNA load, lymphocytes and cytokines [Срок оценки: From enrollment to study completion (up to 24 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07525024 · KSD-101-RW102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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