Recurrent Glioblastoma (rGBM)
Conditions
Interventions
Dose group 1:JL15003 injection single intratumoral administration 1.25×10^6 CCID50
Dose group 2:JL15003 injection single intratumoral administration 5.0×10^6 CCID50
Dose group 3:JL15003 injection single intratumoral administration 2.0×10^7 CCID50
Dose group 4:JL15003 injection single intratumoral administration 8.0×10^7 CCID50
Sponsors
Huashan Hospital, Shanghai Medical College, Fudan University
Beijing TianTan Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions (>=1 cm and =70 and expected survival time >= 3 months; 6. CD155 expression confirmed by immunohistochemistry (H-Score >=1); 7. Patients should have received a boost immunization with trivalent inactivated between 1 week to 6 months prior to administration of the study agent, 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 6 months 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.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin; 2. Patients with an impending, life-threatening cerebral herniation syndrome; 3. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5 F/37.5 C);; 4. Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or organ transplantation; 5. Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association (NYHA) Class 3 or 4) or uncontrolled diabetes mellitus; 6. Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease; 7.Patients with diffuse subependymal disease; 8. Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or postoperative tumor cavity connecting to the ventricle; 9. Patients with a previous history of neurological complications due to poliovirus infection; 10. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups);; 11. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin; 12. Patients who have received antitumor therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy, TTFields, or other investigational antitumor drugs) within 4 weeks prior to the first dose of the study drug or within 5 half-lives of the previous drug (whichever is longer), and has not recovered from the toxicities (i.e., to =1.2 × upper limit of normal (ULN); ? Serum total bilirubin (TBIL) , AST, ALT >2.5 × ULN; ? Neutrophil count 1.5 × ULN; 19. Patients with positive syphilis antibody, or active hepatitis [For hepatitis B: positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV-DNA copy number above the upper limit of normal; for hepatitis C: positive HCV antibody and HCV RNA copy number above the upper limit of normal]; 20. Subjects who meet any of the followin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events (AEs);The occurrence of dose limiting toxicity (DLT);The Maximum tolerated dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Viral shedding;Expression of CD155.;Disease control rate (DCR);Progression-free survival (PFS);Duration of response (DOR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactWu Jinsong Zhang Jing
Huashan Hospital, Shanghai Medical College, Fudan University
Outcome results
None listed