KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Exclusion Criteria

• •1. History of another primary malignancy that has not been in continuous remission for at least 2 years, except for the following conditions which are exempt from the 2-year limit: non-melanoma skin cancer, Stage I solid tumors treated with curative intent and low risk of recurrence, cured localized prostate cancer, biopsy-confirmed carcinoma in situ of the cervix, or squamous intraepithelial lesion identified on Pap smear.
• •2. Uncontrolled infectious disease within 4 weeks prior to enrollment.
• •3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• •4. HIV infection.
• •5. Positive for Treponema pallidum(syphilis).
• •6. Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.
• •7. History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines).
• •8. Participation in any other clinical trial within 4 weeks prior to enrollment.
• •9. History of clinically significant central nervous system (CNS) diseases, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.
• •10. Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation.
• •11. History of severe cardiovascular conditions within the past 6 months.
• •12. Presence of psychiatric illness.
• •13. History of drug abuse or addiction.
• •14. Use of the following medications or therapies:
• •1. Corticosteroids (physiologic replacement doses, and topical or inhaled steroids are permitted).
• •2. Chemotherapy.
• •3. GvHD Therapy.
• •4. Allogeneic hematopoietic stem cell transplantation.
• •5. Gene therapy.
• •15. Women who are breastfeeding.
• •16. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures (including follow-up visits) or unlikely to comply with the requirements for participation in this study.