JL-15003

This is a single-arm, open-label, single-dose study consisting of a dose-escalation phase followed by a dose-expansion phase. Four dose levels are planned. Dose escalation will be conducted using an accelerated titration combined with a traditional "3+3" design. A total of 27 to 33 subjects are planned to be enrolled. The primary objective is to evaluate safety, with secondary objectives exploring efficacy and viral shedding. The study duration, from the first subject enrolled to the completion of the last subject's observation period (Day 57 visit), is estimated to be 1 to 2 years. A long-term survival follow-up period of approximately 15 years, or until all subjects are lost to follow-up or deceased, is planned. All data up to Day 57 will be used to support the initiation of a Phase II clinical trial. Any safety and efficacy data will be submitted to regulatory authorities on a rolling basis during the trial.

主要目的： 评价JL15003注射液治疗复发胶质母细胞瘤患者的安全性和耐受性。 次要目的： 初步评价JL15003对复发胶质母细胞瘤患者的疗效，为II期临床试验的给药剂量提供依据； 观察JL15003在瘤内给药后的病毒脱落情况； 探索复发胶质母细胞瘤患者肿瘤组织中与JL15003疗效相关的生物标志物。