A Phase I Clinical Study of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hematological Malignancies

Exclusion Criteria

• •1. Received chemotherapy or immunosuppressive therapy within 4 weeks prior to leukapheresis or radiotherapy within 2 weeks prior to leukapheresis.
• •2. Underwent allogeneic transplantation prior to enrollment.
• •3. Received (attenuated) live vaccines within 4 weeks prior to enrollment.
• •4. Participated in other clinical studies within 4 weeks prior to enrollment and received at least one dose of the investigational product.
• •5. Underwent therapeutic surgery within 4 weeks prior to enrollment, or plan to undergo major surgery during the study, except diagnostic, biopsy and drainage procedures.
• •6. Presence of uncontrolled infectious disease within 4 weeks prior to enrollment, except EBV infection.
• •7. Receiving systemic corticosteroid therapy prior to screening and require long-term systemic corticosteroids during the treatment period (except inhalation or topical application) as judged by the investigator, or received systemic corticosteroid therapy (except inhalation or topical application) within 72 hours prior to administration.
• •8. Active central nervous system metastases/lesions (e.g., brain edema requiring hormone intervention or brain metastases).
• •9. Severe cardiovascular diseases:
• •* Grade ≥ 3 cardiovascular diseases according to the New York Heart Association (NYHA) classification within 6 months prior to enrollment.
• •* Unstable angina or severe arrhythmias requiring medication.
• •* Other significant ECG abnormalities, including second-degree type 2 atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate \< 50 beats/min with clinical symptoms), etc.
• •10. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and increased peripheral blood hepatitis B virus (HBV) DNA titer above the ULN; positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis-specific antibodies.
• •11. Have not recovered to normal or Grade ≤ 1 from prior treatment-induced AEs prior to enrollment, except alopecia (any grade) and peripheral neuropathy (Grade ≤ 2).
• •12. Other active malignancies within the past 3 years, except for curable cancers that have been markedly cured, such as basal or squamous cell carcinoma, cervical or breast cancer in situ.
• •13. Prior history of severe drug allergies or history of penicillin allergy.
• •14. Substance abuse/addiction.
• •15. Women who are pregnant or nursing.
• •16. Other serious medical conditions, including liver disease, kidney disease, neurological/psychiatric disorders, endocrine disorders, hematologic disorders, and immune system disorders, which will render a subject unsuitable for participation in the study as judged by the investigator.
• •17. Other conditions that render a subject unsuitable for enrollment as judged by the investigator.