KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial (NCT05635591) | Clinical Trial Compass
By InvitationPhase 1
KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial
China9 participantsStarted 2023-01-16
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. The patient or his legal guardian participated voluntarily and signed the informed consent form.
✓. A patient aged 18 - 70 years ( inclusive ) on the day of signing the informed consent form, male or female.
✓. 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.
✓. ECOG performance score 0 - 1.
✓. Meet apheresis or intravenous blood collection criteria and no other contraindications.
✓. 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.
✓. A patient who has a lymph node area where subcutaneous injection can be performed.
Exclusion criteria
✕. A patient who has received any anticancer therapy such as chemotherapy, radiotherapy or immunotherapy (eg, immunosuppressive drugs) within one month prior to screening.
✕. 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.
✕
What they're measuring
1
Incidence of dose-limiting toxicity (DLT) by dose group
Timeframe: 1 years after DC Vaccines injection
2
Incidence of maximally tolerated dose (MTD) by dose grouphaematologic neoplasms
Timeframe: 1 years after DC Vaccines injection
3
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
. 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.
✕. A patient who has central nervous system disorders (e.g., brain oedema, hormonal intervention indicated, or progression of brain metastases).
✕. 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）
✕. A patient who has serious underlying diseases (such as cardiovascular disease, respiratory disorder, renal insufficiency, coagulation disorder, autoimmune disease or immunodeficiency disease, etc.).
✕. 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.
✕. A patient who has received prophylactic live or live-attenuated vaccines within 4 weeks prior to screening