A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)
The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).
• 1\. Age \>= 18 years of age;
• 2\. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions ( \<=3 cm on contrast-enhanced MRI prior to JL15003 administration);
• 3\. Histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification;
• 4\. Refractory or relapsed following standard-of-care therapy or intolerance to standard therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide);
• 5\. Tolerable to intratumoral/intracavitary Ommaya reservoir catheter implantation;
• 6\. Karnofsky Performance Status (KPS) \>=70 and expected survival time \>= 3 months;
• 7\. Patients should have received a boost immunization with trivalent inactivated poliovirus vaccine between 1 week to 6 months prior to administration of the study drug, with a neutralizing antibody titer \>=1:8 prior to the administration;
• 8\. Able to undergo brain MRI with and without contrast;
• 9\. All subjects and their partners must have no plans for conception from screening until 90 days after the end of the observation period and must agree to use effective non-pharmacological contraceptive measures during the trial;
• 10\. Subjects voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.