A Phase I Study to Evaluate the Safety and Tolerability of JL15003 Injection in Patients With Recurrent Glioblastoma

NCT07497373 | Completed Phase 1

• 1 other identifier: Jecho-15003-I
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, single-dose study consisting of a dose-escalation phase followed by a dose-expansion phase. Four dose levels are planned. Dose escalation will be conducted using an accelerated titration combined with a traditional "3+3" design. A total of 27 to 33 subjects are planned to be enrolled. The primary objective is to evaluate safety, with secondary objectives exploring efficacy and viral shedding. The study duration, from the first subject enrolled to the completion of the last subject's observation period (Day 57 visit), is estimated to be 1 to 2 years. A long-term survival follow-up period of approximately 15 years, or until all subjects are lost to follow-up or deceased, is planned. All data up to Day 57 will be used to support the initiation of a Phase II clinical trial. Any safety and efficacy data will be submitted to regulatory authorities on a rolling basis during the trial.

Conditions

Recurrent Glioblastoma Multiforme(GBM)

Outcome Measures

Primary Outcomes (3)

• The incidence and severity of adverse events (AEs)

  From date of randomization until the date of death from any cause, assessed up to 180 months

• The occurrence of dose limiting toxicity (DLT)

  Within 28 days after the first administration

• The Maximum tolerated dose (MTD)

  After DLT observation in each dose group and after efficacy evaluation in each dose group，up to 3 years

Secondary Outcomes (7)

• Objective response rate (ORR)

  From date of drug administration until the date of disease progression, or death from any cause, assessed up to 12 months

• Viral shedding:Copy number of JL15003 in blood, throat swab, and fecal samples

  From the first administration to Week 8.

• Expression of CD155

  From signing the informed consent form to day 28

• Disease control rate (DCR)

  Up to 12 months

• Progression-free survival (PFS)

  Up to 15 years

Study Arms (1)

Single intratumoral administration of JL15003 Injection

EXPERIMENTAL

Single intratumoral administration of JL15003 Injection

Biological: JL15003 Injection

Interventions

JL15003 Injection BIOLOGICAL

Single intratumoral administration of JL15003 Injection

Single intratumoral administration of JL15003 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old;
• Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions (≥1 cm and ≤5.5 cm on contrast-enhanced MRI prior to drug administration).
• Prior histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification.
• Refractory or relapsed following standard-of-care therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide);
• Karnofsky Performance Status (KPS) ≥70 and expected survival time ≥ 3 months;
• CD155 expression confirmed by immunohistochemistry (H-Score ≥1);
• 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;
• Able to undergo brain MRI with and without contrast;
• 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;
• Subjects voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.

You may not qualify if:

• Patients who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;
• Patients with an impending, life-threatening cerebral herniation syndrome;
• Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \> 99.5 F/37.5 C);;
• Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or organ transplantation;
• 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;
• Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease;
• Patients with diffuse subependymal disease;
• Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or postoperative tumor cavity connecting to the ventricle;
• Patients with a previous history of neurological complications due to poliovirus infection;
• Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups);;
• 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;
• 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);
• Patients have received bevacizumab ≤ 6 weeks and could not exclude pseudo relievers caused by anti angiogenic inhibitors;
• 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;
• 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;

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Huashan Hospital, Shanghai Medical College, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 27, 2026
• Study Start: November 16, 2022
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)