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

Обзор

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).

Вмешательства

• Биопрепарат Autologous monocyte - derived DCs pulsed with EBV antigen
  Patients will receive approximately （5-10）x10\^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times.Doses 4 and 5 are designated as booster doses. The need for booster treatment and the exploration of alternative immunization schedules shall be determined by the Investigator based on the subject's condition.For subjects in the dose expansion phase, concomitant therapy recommended by the Investigator is permitted if the subject has a high tumor burden. In the event of disease prog

Первичные конечные точки

• Incidence of dose-limiting toxicity (DLT) by dose group [Срок оценки: 1 years after DC Vaccines injection]
• Incidence of maximally tolerated dose (MTD) by dose grouphaematologic neoplasms [Срок оценки: 1 years after DC Vaccines injection]
• Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group [Срок оценки: 1 years after DC Vaccines injection]

Вторичные конечные точки (9)

• EBV-DNA load [Срок оценки: 1 years after DC Vaccines injection]
• Objective response rate (ORR) [Срок оценки: 1 years after DC Vaccines injection]
• Disease control rate (DCR) [Срок оценки: 1 years after DC Vaccines injection]
• Duration of response (DOR) [Срок оценки: 1 years after DC Vaccines injection]
• Progression-free survival (PFS) [Срок оценки: 1 years after DC Vaccines injection]
• Overall survival (OS) [Срок оценки: 1 years after DC Vaccines injection]
• Levels of EBV-specific CD8+ T cells [Срок оценки: 1 years after DC Vaccines injection]
• Levels of B cells [Срок оценки: 1 years after DC Vaccines injection]
• Levels of NK cells [Срок оценки: 1 years after DC Vaccines injection]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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
• A patient who has participated in other clinical studies within 4 weeks prior to screening
• A patient who has a prior history of serious drug allergy or penicillin allergy.
• A patient who has a history of drug abuse/addiction.
• A patient who has any conditions resulting in ineligibility for enrollment as judged by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Li Chunrui — Ухань

Идентификаторы

NCT: NCT05635591 · KSD-101-CR001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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