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

Prior treatment

• 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.
• Uncontrolled infectious disease within 4 weeks prior to enrollment.
• Participation in any other clinical trial within 4 weeks prior to enrollment.
• Use of the following medications or therapies:
  • Corticosteroids (physiologic replacement doses, and topical or inhaled steroids are permitted).
  • Chemotherapy.
  • GvHD Therapy.
  • Allogeneic hematopoietic stem cell transplantation.
  • Gene therapy.

Other illness

• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• HIV infection.
• Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.
• History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines).
• 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.
• Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation.
• History of severe cardiovascular conditions within the past 6 months.
• Presence of psychiatric illness.
• History of drug abuse or addiction.

Other

• Positive for Treponema pallidum(syphilis).
• Women who are breastfeeding.
• 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.

• Patients or their legal guardians voluntarily participate in the study and provide written informed consent.
• Aged 18 to 80 years (inclusive), male or female.
• ECOG performance status score of ≤ 1.
• Life expectancy \> 3 months.
• KPS score ≥ 70.
• Patients with diffuse large B-cell lymphoma (DLBCL) diagnosed according to the 2016 WHO classification. Patients with DLBCL should have been diagnosed as relapsed or refractory after at least one prior line of systemic therapy.
• CD19 positivity confirmed by flow cytometry and/or histopathology.
• According to the Lugano 2014 criteria, the presence of PET-positive target lesions for tumor assessment is required (Deauville 5-Point Scale \[5-PS\] ≥ 4).
• Adequate organ function.
• Female patients of childbearing potential must have a negative urine/blood pregnancy test during the screening period and agree to use effective contraception for at least 1 year after infusion; male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year after infusion.