[Translation] An open-label, single-arm phase I clinical trial evaluating the safety, tolerability, and efficacy of AVL-101 in patients with cervical intraepithelial neoplasia grade 2/3 (CIN2/3) caused by HPV16/18 infection.
主要目的:1、评估AVL-101注射液在尚未接受治疗的人乳头瘤病毒(HPV)16/18感染引起的CIN2/3患者的安全性和耐受性。2、确定II期临床试验推荐剂量(RP2D),初步制定合理的给药方案。次要目的:1、评估不同剂量水平的AVL-101注射液采用间隔3周共注射3次的给药方案给药后是否可以诱导抗HPV16/18抗原特异性抗体和细胞介导的免疫应答反应。2、初步评价不同剂量水平AVL-101注射液采用间隔3周共注射3次的给药方案治疗HPV16/18感染引起的CIN2/3的有效性。探索性目的:1、探索受试者首次接受AVL-101注射液给药后PK特征,即DNA暴露水平。2、探索受试者接受AVL-101注射液前后外周血中相关细胞因子的水平。
[Translation] Primary Objectives: 1. To evaluate the safety and tolerability of AVL-101 injection in patients with CIN2/3 caused by untreated human papillomavirus (HPV) 16/18 infection. 2. To determine the recommended dose (RP2D) for the Phase II clinical trial and to preliminarily develop a reasonable dosing regimen. Secondary Objectives: 1. To evaluate whether administration of different dose levels of AVL-101 injection, administered three times at 3-week intervals, can induce anti-HPV16/18 antigen-specific antibodies and cell-mediated immune responses. 2. To preliminarily evaluate the efficacy of different dose levels of AVL-101 injection administered three times at 3-week intervals for the treatment of CIN2/3 caused by HPV16/18 infection. Exploratory Objectives: 1. To explore the PK characteristics, i.e., DNA exposure level, of subjects after the first administration of AVL-101 injection. 2. To explore the levels of relevant cytokines in peripheral blood before and after administration of AVL-101 injection.