recurrent glioblastoma (rGBM)
Conditions
Interventions
Dose Group 1:Intratumoral or intracavitary administration of JL15003 Injection
Dose Group 2:Intratumoral or intracavitary administration of JL15003 Injection
Phase II:The administration route, dosage, and sample size of JL15003 will be adjusted based on the Phase Ib results, To be determined (TBD).
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 of age; 2. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions ( =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.
Exclusion criteria
Exclusion criteria: 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; 3. Patients with combined severe or active diseases are defined as follows: (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; (3) Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association (NYHA) Class 3 or 4); (4) History of vascular diseases (including myocardial infarction, unstable angina pectoris, cerebrovascular disease, peripheral arterial disease, or aortic disease, etc.) within 6 months; (5) Uncontrolled hypertension (defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg on at least 2 separate occasions, despite antihypertensive medication); (6) Patients with active thrombosis, active bleeding, or pathological conditions posing a high risk of bleeding (e.g., coagulation disorders); (7) Patients with active autoimmune disease requiring systemic immunomodulatory therapy within 3 months; 4. Patients with known history of agammaglobulinemia; 5. Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease; Subjects with diffuse subependymal disease; 6. Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or postoperative tumor cavity connecting to the ventricle; The tumor crosses the midline; 7. Patients with a history of neurological complications due to poliovirus infection; 8. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups); 9. 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; 10. 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 1.5 × upper limit of normal (ULN); (5) Serum total bilirubin (TBIL) > 1.5×ULN; (6) AST/ALT> 2.5×ULN; (7) Prothrombin and Partial Thromboplastin Times >1.2×ULN; 14. Subjects with positive syphilis antibody, or act
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any changes in the incidence and severity of Adverse Events (AEs);Clinical laboratory test results;Electrocardiograms (ECG);Vital signs and physical examination;Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), 12-month OS rate, Objective response rate (ORR), Disease control rate (DCR), Progression-free survival (PFS), Duration of response (DOR);Copy number and CCID50 (if qRT-PCR positive) of JL15003 in blood, throat swab, fecal, cerebrospinal fluid (CSF) and cystic fluid samples;Objective response rate (ORR), Disease control rate (DCR), Progression-free survival (PFS), Duration of response (DOR);Cytokine analysis of blood, cerebrospinal fluid, and cystic fluid samples;Any changes in the incidence and severity of Adverse Events (AEs) /clinical laboratory test results/lectrocardiograms (ECG)/vital signs and physical examination; | — |
Countries
China
Contacts
Public ContactWu Jinsong;Zhang Jing
Huashan Hospital, Shanghai Medical College, Fudan University
Outcome results
None listed