NCT06885710招募中1 期
Safety and Efficacy of Hepatitis B Virus (HBV)-Specific T Cell Receptor (TCR)-T Cell Therapy Combined With Nucleos(t)Ide Analogues (NAs) in HBeAg-Positive Chronic Hepatitis B Patients
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Assessments of adverse events
研究概览
简要总结
This is a open-label study to evaluate the safety and efficacy of autologous T-cells transfected with messenger ribonucleic acid (mRNA) encoding Hepatitis-B virus (HBV) antigen specific T cell receptor (TCR) in combination with nucleos(t)ide analogues (NAs) in HBeAg-positive and negative chronic hepatitis B patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHB infection (Serum HBsAg-positive for ≥ 6 months)
- •Serum HBeAg-positive or negative
- •HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A*02:01, A*11:01 or A*24:02).
- •Liver biopsy, Fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis (≥Metavir 3).
排除标准
- •History or other evidence of chronic liver disease unrelated to HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, non-alcoholic fatty liver disease)
- •Decompensated liver function, such as Child-Pugh grade B or C, or clinical signs of decompensated liver function like ascites and varices
- •Positive HIV test result
- •History or suspected diagnosis of hepatocellular carcinoma, or AFP at screening > 20 ng/mL (if AFP > 20 ng/mL, a liver scan result is required to exclude hepatocellular carcinoma)
研究组 & 干预措施
LioCyx-M (Autologous T-cells transfected with mRNA encoding HBV antigen specific TCR)
Experimental
Escalating doses of LioCyx-M from 5×10E05 to 50×10E06 cells/kg body weight (BW), administered every two weeks.
干预措施: LioCyx-M (Biological)
结局指标
主要结局
Assessments of adverse events
时间窗: Start of treatment until 28 days post last dose
To evaluate the safety of LioCyx-M
次要结局
- Changes in HBeAg levels(Up to 1 year after last dose)
- Changes in HBeAb levels(Up to 1 year after last dose)
- Changes in HBsAg levels(Up to 1 year after last dose)
研究者
研究点 (1)
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不适用
ongitudinal analysis of HBV-specific T cell responses in patients with HBeAg-negative chronic hepatitis B (CHB) treated with pegylated interferon alfa-2a (40 KD) (PEGASYS, Ro 25-8310). Immunology sub-study for a selected subgroup of patients participating in study ML 18253chronic hepatitis B, HBeAg-negativeMedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2005-000336-25-ITROCHE