A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Optimal treatment dosage
研究概览
简要总结
This study represents a phase I clinical trial that utilizes natural killer (NK) cell therapy for patients diagnosed with liver cancer, specifically those classified as Child-Pugh A and falling within the Barcelona Clinic Liver Cancer (BCLC) stages B or C. The expected results include determining the suitable treatment dosage, identifying any resulting side effects, and calculating the average duration of progression-free survival. The target group for the study consists of all individuals diagnosed with liver cancer. At the same time, the practical sample consists of those who received medical care for liver cancer at Cipto Mangunkusumo Hospital (RSCM) between May and December 2022. The chosen research sample comprises liver cancer patients who fulfill the predetermined participation criteria. The necessary sample size for discerning appropriate treatment dosages and the occurrence rate of potential side effects shall consist of 2-3 liver cancer patients who are administered autologous NK cells. The process for isolating these NK cells adheres to the guidelines established by Miltenyi Biotec.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20-60 years old
- •Patients with Hepatocellular Carcinoma (HCC) staged as BCLC B and C
- •Karnofsky Performance Status (KPS) score ≥ 70
- •Expected patient survival of more than three months
- •The following parameters are within the normal range:
- •Platelet count ≥ 80,000/µL White blood cell count ≥ 3000/µL Neutrophil count ≥ 2000 Hemoglobin ≥ 9 mg/dL International Normalized Ratio (INR) 0.8-1.5 Adequate liver function (bilirubin < 2, SGOT and SGPT < 60 U/L) Adequate kidney function (serum creatinine < 1.3, serum urea < 10)
排除标准
- •Refusing to participate in the study
- •Afflicted by other malignancies, whether non-HCC liver or other malignancies
- •Patients are affected by other conditions such as hypertension, severe coronary disease, myelosuppression, respiratory disorders, and acute or chronic infections
- •Patients who have previously undergone transplantation and received other stem cell therapies
研究组 & 干预措施
Autologous Natural Killer Cell
Dosage Form: Autologous Natural Killer (NK) Cells. These cells will be harvested from the patient's body and infused back into the patient.
Dosage: The specific dose quantity will be determined based on the patient's medical condition and response to the treatment. Customized dosages will be calculated for each individual.
Frequency: The treatment will be given through an intravenous method.
Duration: The length of the treatment will vary depending on how the patient responds and their medical assessment. It may take several weeks to evaluate its effectiveness and potential impacts thoroughly.
干预措施: Autologous Natural Killer Cell Therapy (Drug)
Autologous Natural Killer Cell
Dosage Form: Autologous Natural Killer (NK) Cells. These cells will be harvested from the patient's body and infused back into the patient.
Dosage: The specific dose quantity will be determined based on the patient's medical condition and response to the treatment. Customized dosages will be calculated for each individual.
Frequency: The treatment will be given through an intravenous method.
Duration: The length of the treatment will vary depending on how the patient responds and their medical assessment. It may take several weeks to evaluate its effectiveness and potential impacts thoroughly.
干预措施: Clinimacs Plus (Device)
结局指标
主要结局
Optimal treatment dosage
时间窗: Start of infusion of Autologous NK cells (Day 0) until up to 6 months
To evaluate the safety of autologous NK cell infusion and discover dose-limiting toxicities (DLT). This evaluation will determine the recommended dosage for the next trial phase.
次要结局
- Immunological Responses(Up to 6 months)
- Progression-free survival(Start of infusion of Autologous NK cells (Day 0) until progressive disease or death, whichever comes first, up to 2 years)
- Tumor Shrinkage(Up to 6 months)
- Hematology Profile(Start of infusion of Autologous NK cells (Day 0) until up to 6 months)
研究者
Cosphiadi Irawan
Head of Hematology-Medical Oncology Division, Dr Cipto Mangunkusumo General Hospital
Dr Cipto Mangunkusumo General Hospital