NCT05783570Unknown1 期
A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 Targeted Chimeric Antigen Receptor T Cell Therapy in Patients With GPC3 Positive Advanced Hepatocellular Carcinoma Who Have Failed Standard Therapy
Eutilex8 个研究点 分布在 2 个国家目标入组 12 人开始时间: 2023年8月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Development of anti-drug antibodies (ADA)
研究概览
简要总结
To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy
详细描述
A Dose-escalation, Single-arm, Open-Label, Phase 1 Study
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible, subjects must meet all of the following criteria:
- •Male or female adults ≥19 years old at the time of written informed consent
- •Patients with histologically or cytologically diagnosed unresectable HCC refractory to first- or second-line standard therapy* with no other standard therapy available
- •* Including, but not limited to atezolizumab plus bevacizumab combination therapy and tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib).
- •Confirmed GPC3 positivity by IHC based on a liver tissue sample
- •At least 1 measurable lesion based on mRECIST v1.1
- •Child-Pugh score Class A or Class B(7)
- •Life expectancy ≥3 months based on the judgment of the investigator
- •ECOG PS 0 or 1
- •Patients who have adequate bone marrow, liver, and kidney functions at the time of screening:
- •WBC ≥ 2,000 /μL ANC ≥ 1,000 /μL Platelet ≥ 80,000 /μL Hemoglobin ≥ 9.0 g/dL Albumin ≥ 2.8 g/dL AST and ALT ≤ 5ⅹULN Total bilirubin ≤ 2 x ULN Serum creatinine ≤1.5 x ULN Creatinine clearance (CrCl) ≥ 30 mL/min PT(INR) ≤1.5 x ULN
- •Negative serum pregnancy test in women of childbearing potential
- •Women of childbearing potential or men who do not plan a pregnancy during the study period and who agree to use clinically adequate methods of contraception as follows:
- •* Hormone contraceptives (subcutaneous implants, injections, oral contraceptives, etc.), intrauterine device (IUD) (or intra uterine system [IUS]), subject's or partner's surgical sterilization (vasectomy, tubal ligation, etc.), double barrier methods (combined use of barrier methods such as combined use of cervical cap or diaphragm plus male condom)
- •Written informed consent to voluntary study participation
排除标准
- •Subjects who meet any of the following criteria cannot participate in the study:
- •Current disease and medical history
- •History or current evidence of hepatic encephalopathy
- •Patients with radiographic findings of brain metastases or spinal cord compression
- •Histologically confirmed HCC in ≥50% of the liver
- •Severe ascites requiring treatment such as paracentesis
- •History or current evidence of the following infections:
- •Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
- •Active hepatitis B (However, if HBsAg is positive, and if it is low or undetectable HBV DNA (HBV DNA level <2,000 IU/mL) based on the site-specific criteria at screening and a prophylactic antiviral agent can be administered for 6 months after the administration of the investigational product, enrollment is possible at the discretion of the investigator.)
- •Active hepatitis C (However, patients who have undergone antiviral therapy and whose HCV viral load is negative based on the site-specific criteria will be allowed to be enrolled.)
- •Uncontrolled severe chronic infection or active infection
- •Prior or planned organ transplantation during the study period
- •Diagnosis of any malignant tumor other than the study indication within 5 years prior to screening (Patients who were treated and assessed as complete response [CR] without recurrence within 3 years or patients diagnosed with nonmelanoma skin cancer, in-situ disease, thyroid cancer, or borderline tumor will be allowed to be enrolled.)
- •Clinically significant, severe cardiac disease based on the judgment of the investigator (e.g., uncontrolled hypertension, congestive heart failure [NYHA Grade ≥2], ventricular arrhythmia, active ischemic heart disease, history of myocardial infarction within 1 year prior to screening), renal impairment, or respiratory disease
研究组 & 干预措施
EU307 CAR-T Cell
Experimental
干预措施: EU307 CAR-T Cell (Biological)
结局指标
主要结局
Development of anti-drug antibodies (ADA)
时间窗: up to 6 month from LPI
AEs (including DLT)
时间窗: up to 6 month from LPI
In this study, DLT is defined as an AE related to the IP (EU307),and severity will be assessed according to NCI-CTCAE v5.0
Production of replication competent lentiviruses (RCL)
时间窗: up to 6 month from LPI
次要结局
- OS(up to 6 month)
- ORR(up to 6 month)
- DoR(up to 6 month)
- TTR(up to 6 month)
- TTP(up to 6 month)
- DCR(up to 6 month)
- PFS(up to 6 month)
研究者
研究点 (8)
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