CELL INTELLIGENCE · 肿瘤细胞治疗研究

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.

主要终点：Overall Response Rate · The proportion of patients with complete and partial response after treatment. · Baseline up to 24 months after DC vaccines injection.
次要终点：Complete Response Rate；Disease Control Rate；Duration of Response；Progression-free survival；Overall survival rate；Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0；Changes of EBV DNA load, lymphocytes and cytokines

• KSD-101 therapy

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.