ksd-101 therapy for ebv-associated haematologic neoplasms: an exploratory clinical trial

Conditions: EBV-associated Haematologic Neoplasms

Summary: the primary objectives of this study is to evaluate the tolerability and safety of ksd-101 in patients with ebv-associated haematologic neoplasms, observe the dose-limiting toxicity (dlt) and and to explore the maximum tolerated dose (mtd).


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.

Keywords: ebv haematologic neoplasms