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
Qualifiers
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
Treatments tested in this trial
- JL15003Injection