NCT05635591Enrolling By Invitation1 期
KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of dose-limiting toxicity (DLT) by dose group
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •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.
研究组 & 干预措施
KSD-101
Experimental
干预措施: Autologous monocyte - derived DCs pulsed with EBV antigen (Biological)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT) by dose group
时间窗: 1 years after DC Vaccines injection
Dose limiting toxicity will be assessed after injection in each dose group
Incidence of maximally tolerated dose (MTD) by dose grouphaematologic neoplasms
时间窗: 1 years after DC Vaccines injection
Maximally tolerated dose will be assessed after injection in each dose group
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
时间窗: 1 years after DC Vaccines injection
Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after injection, those related to study drug, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity.
次要结局
- Objective response rate (ORR)(1 years after DC Vaccines injection)
- EBV-DNA load(1 years after DC Vaccines injection)
- Overall survival (OS)(1 years after DC Vaccines injection)
- Levels of EBV-specific CD8+ T cells(1 years after DC Vaccines injection)
- Duration of response (DOR)(1 years after DC Vaccines injection)
- Disease control rate (DCR)(1 years after DC Vaccines injection)
- Levels of NK cells(1 years after DC Vaccines injection)
- Progression-free survival (PFS)(1 years after DC Vaccines injection)
- Levels of B cells(1 years after DC Vaccines injection)
研究者
Chunrui Li
Principal Investigator
Tongji Hospital
研究点 (1)
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