A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)

This is a multicenter, open-label, Phase Ib clinical trial with an on-demand dosing design, evaluating the safety and efficacy of JL15003 Injection in patients with recurrent glioblastoma (rGBM). The trial consists of a Screening Period (Week -5 to Week -1), a Treatment Period (from Week 1 until protocol-defined treatment discontinuation criteria are met), and a Survival Follow-up Period (up to 15 years or until all subjects are lost to follow-up or deceased).

The Phase Ib is going to enroll 40 subjects into two dose cohorts: Cohort 1 (5×10⁶ CCID₅₀, n=20) and Cohort 2 (8×10⁷ CCID₅₀, n=20). Enrollment will proceed sequentially, starting with Cohort 1, followed by Cohort 2, after the former is completed. All subjects will receive the first dose of their assigned dose level on Day 1 of Week 1 (W1D1). During the Treatment Period, the Investigator will determine the need for repeat dosing based on a comprehensive assessment of efficacy and safety, with a minimum interval of 8 weeks between doses. The number of doses is not limited. Treatment will continue until the investigator assesses disease progression, intolerable toxicity, the need for new anti-tumor therapy (except for on-demand bevacizumab for cerebral edema control), withdrawal of informed consent, death, loss to follow-up, or other protocol-specified discontinuation criteria.

The sample size and design for Phase II will be determined based on the Phase Ib results.