KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial

Launched by TONGJI HOSPITAL · Nov 22, 2022

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Eligibility criteria

• Inclusion Criteria:
• • 1. The patient or his legal guardian participated voluntarily and signed the informed consent form.
• • 2. A patient aged 18 - 70 years ( inclusive ) on the day of signing the informed consent form, male or female.
• • 3. A patient who is diagnosed with EBV - associated haematologic neoplasms，and fail to respond or relapse after conventional treatment, or voluntarily choose therapeutic DC vaccines as the salvage therapy.
• • 4. ECOG performance score 0 - 1.
• • 5. Meet apheresis or intravenous blood collection criteria and no other contraindications.
• • 6. Adequate organ function:Hematology: neutrophils of ≥1×10\^9 /L , hemoglobin of ≥ 70 g / L, platelets of ≥ 50 ×10\^9 / L. Liver function: ALT, AST ≤ 3 × ULN and TBIL ≤ 1.5 × ULN.Renal function: creatinine ≤ 1.5 × ULN. Cardiac function: left ventricular ejection fraction LVEF ) ≥ 40%. Coagulation function: fibrinogen ≥ 1.0 g / L, activated partial thromboplastin time ( APTT ) ≤ 1.5 × ULN, prothrombin time ( PT ) ≤ 1.5 × ULN.
• • 7. A patient who has a lymph node area where subcutaneous injection can be performed.
• Exclusion Criteria:
• • 1. A patient who has received any anticancer therapy such as chemotherapy, radiotherapy or immunotherapy (eg, immunosuppressive drugs) within one month prior to screening.
• • 2. A female patient who is pregnant (positive urine/blood pregnancy test) or breastfeeding, or a male/female patient who plans to conceive in recent 1 year.
• • 3. A patient who has positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with positive titer of hepatitis B virus (HBV) DNA in peripheral blood; or has positive hepatitis C virus (HCV) antibody, hepatitis C virus (HCV) RNA in peripheral blood, human immunodeficiency virus (HIV) antibody, or syphilis.
• • 4. A patient who has central nervous system disorders (e.g., brain oedema, hormonal intervention indicated, or progression of brain metastases).
• • 5. Patients had an uncontrollable infectious disease within the first 4 weeks of enrollment（ except the CTCAE toxicity grade is less than 2 of genitourinary infections and upper respiratory tract infections , EBV infection）
• • 6. A patient who has serious underlying diseases (such as cardiovascular disease, respiratory disorder, renal insufficiency, coagulation disorder, autoimmune disease or immunodeficiency disease, etc.).
• • 7. A patient who has had other active malignancies within the last 3 years, unless curable and clearly cured, such as basal or squamous cell carcinoma, carcinoma in situ of cervix or breast, etc.
• • 8. A patient who has received prophylactic live or live-attenuated vaccines within 4 weeks prior to screening
• • 9. A patient who has participated in other clinical studies within 4 weeks prior to screening
• • 10. A patient who has a prior history of serious drug allergy or penicillin allergy.
• • 11. A patient who has a history of drug abuse/addiction.
• • 12. A patient who has any conditions resulting in ineligibility for enrollment as judged by the investigator.