NCT07493044招募中1 期
An Open-Label, Phase I Clinical Trial of GPC3-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (Super CAR-T) for the Treatment of Patients With Advanced Hepatocellular Carcinoma
Guangzhou FineImmune Biotechnology Co., LTD.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年3月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
详细描述
After the subjects signed the informed consent form,the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the GPC3 immunohistochemistry was positive. Each subject received only one cell infusion.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities;
- •Be between 18 and 75 years of age; gender is not restricted;
- •Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7;
- •Previous failure of or intolerance to at least two lines of standard systemic therapy;
- •The subject must provide a tumor sample or biopsy specimen collected within the past 2 years that meets the requirements and tests positive for GPC3 expression via immunohistochemistry;
- •At least one measurable lesion according to RECIST 1.1 criteria;
- •ECOG performance status of 0-1;
- •Expected survival of more than 3 months;
- •Echocardiography showing a left ventricular ejection fraction (LVEF) ≥50%;
- •Laboratory test results must meet at least the following criteria:
- •ANC ≥1.0×10⁹/L; PLT ≥75×10⁹/L; Hb ≥ 75 g/L; Creatinine clearance ≥ 60 mL/min; AST ≤ 5×ULN; ALT≤ 5×ULN; TBIL ≤ 3×ULN;
- •If HBsAg-positive or HBcAb-positive, HBV-DNA must be ≤ 2000 IU/mL;
- •Women of childbearing potential must have a negative pregnancy test prior to receiving study treatment; they must agree to use effective contraception during treatment.
排除标准
- •The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial;
- •The subject is allergic to any component of the drugs to be used in this study, including but not limited to cyclophosphamide, fludarabine, CAR-T products, or their excipients;
- •Has not recovered from adverse reactions related to prior surgery or treatment to Grade ≤ 2; exceptions include alopecia, hyperpigmentation, and other conditions deemed by the investigator not to affect the subject's tolerability;
- •Has a clinically significant central nervous system (CNS) disorder (e.g., epilepsy, severe cerebrovascular stenosis) or other diseases presenting with significant neurological symptoms (including psychiatric disorders);
- •Received radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors for the study disease within 2 weeks prior to apheresis; or received small-molecule targeted therapies such as sorafenib, regorafenib, or lenvatinib within 1 week prior to apheresis;
- •Received systemic glucocorticoid therapy within 7 days prior to single-plasma donation; patients currently using or who have recently used inhaled or topical glucocorticoids, as well as those on physiological-dose replacement therapy, are eligible for enrollment;
- •Any uncontrolled active infection, including but not limited to active tuberculosis or infectious diseases requiring systemic treatment;
- •Known active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, multiple sclerosis, and glomerulonephritis (patients with vitiligo are not excluded);
- •History of organ transplantation, autologous/allogeneic stem cell transplantation, or renal replacement therapy;
- •HCV antibody-positive with HCV RNA levels above the lower limit of detection; HIV antibody-positive; syphilis antibody-positive;
- •Currently pregnant or breastfeeding, or planning to become pregnant during the study;
- •Participants deemed by the investigator to be unable or unwilling to comply with the requirements of the study protocol.
研究组 & 干预措施
Dose escalation was performed in a 3+3 design
Experimental
The Super CAR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3
干预措施: Super CAR-T (Biological)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: 28 days after cell infusion
Determining the DLT of Super CAR-T adoptive Immunotherapy.
Maximum Tolerated Dose (MTD)
时间窗: 28 days after cell infusion
Determining the MTD of Super CAR-T adoptive Immunotherapy.
次要结局
- Objective Response Rate(ORR)(Research period)
- Progression Free Survival(PFS)(One year after cell infusion)
- Overall Survival (OS)(One year after cell infusion)
研究者
研究点 (1)
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