Experimental shot takes on deadly brain tumor
NCT ID NCT07497373
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a single injection of JL15003 in 17 adults whose glioblastoma brain cancer had returned after standard treatments. The main goal was to check safety and find the best dose, while also looking at whether the virus in the injection spreads in the body and if the tumor shrinks. Participants were followed for 57 days, with long-term survival tracked for up to 15 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions (≥1 cm and ≤5.5 cm on contrast-enhanced MRI prior to drug administration). 3. Prior histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification. 4. Refractory or relapsed following standard-of-care therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide); 5. Karnofsky Performance Status (KPS) ≥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: 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 ≤ Grade 1 per CTCAE v5.0, except for alopecia; peripheral neuropathy up to Grade 2 is acceptable); 13. Patients have received bevacizumab ≤ 6 weeks and could not exclude pseudo relievers caused by anti angiogenic inhibitors; 14. Patients who have received Chinese medicine or traditional Chinese patent medicines with anti-tumor effect within 2 weeks prior to the administration of the test drug; 15. Patients who have received radiation therapy within 12 weeks prior to the administration of the investigational drug, excluding those who have undergone radiation therapy for progressive diseases outside the radiation area and cannot rule out pseudoprogression after radiation/chemotherapy; 16. Patients with known history of agammaglobulinemia; 17. Patients on greater than 4 mg per day of dexamethasone or equivalent doses of other hormones (inhaled or localized use of hormones, in the absence of active autoimmune disease) within 2 weeks prior to the administration of the investigational drug; 18. The laboratory tests before biopsy and administration of the test drug meet the following standards: * International Normalized Ratio (INR) and Prothrombin Time (PT) ≥1.2 × upper limit of normal (ULN); * Serum total bilirubin (TBIL) , AST, ALT \>2.5 × ULN; * Neutrophil count \<1.5×109/L; * Hemoglobin \<90g/L; * Platelet count \<100×109/L; * Creatinine \> 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 following criteria and have a positive laboratory test result (e.g., T-SPOT.TB test, tuberculosis antibody assay, or tuberculin skin test) that, in the investigator's judgment, indicates an active or suspected tuberculosis (TB) infection. * Chest imaging suggests suspicious tuberculosis (TB) infection lesions; * Active pulmonary tuberculosis; * History of recurrent tuberculosis within 3 years; * Contact with or family environment with active tuberculosis patients. 21. Subjects who have received any vaccination within 4 weeks prior to the administration of the study drug, with the exception of the trivalent inactivated poliovirus vaccine, non-live seasonal influenza vaccines, or inactivated COVID-19 vaccines; 22. Pregnancy or lactation, and a woman of childbearing potential who has a positive pregnancy test (within 7 days) prior to treatment; 23. Subjects who are unsuitable for participation in this study at the Investigator's discretion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Tsinghua Changgung Hospital
Beijing, China
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Huashan Hospital, Shanghai Medical College, Fudan University
Shanghai, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.