About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
1. Subjects who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;
2. Patients with life-threatening cerebral hernia syndrome as determined by the investigator;
(1) Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5 F/37.5 C) for more than a week;
(2) Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or organ transplantation;
Trial design
Single group
Treatments tested in this trial
JL15003Injection
Biological/VaccineIntratumoral or intracavitary administration of JL15003 Injection as needed
Treatment groups
Trial outcomes
Primary outcomes
Any changes in the incidence and severity of Adverse Events (AEs)
Secondary outcomes
Overall survival (OS)
12-month OS rate
Objective response rate (ORR)
Disease control rate (DCR)
Sponsors and contacts
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