A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)

NCT07501559 | Recruiting Phase 1

• 1 other identifier: Jecho-15003-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).

Conditions

Recurrent Glioblastoma Multiforme(GBM)

Outcome Measures

Primary Outcomes (1)

• Any changes in the incidence and severity of Adverse Events (AEs)

  From the signing of the informed consent by the first subject to the end of the study，up to 15 years

Secondary Outcomes (11)

• Overall survival (OS)

  Up to 15 years

• 12-month OS rate

  From the first administration to 12 months after the first administration

• Objective response rate (ORR)

  Up to 12 months

• Disease control rate (DCR)

  Up to 12 months

• Progression-free survival (PFS)

  Up to 15 years

Study Arms (1)

administration of JL15003 Injection

EXPERIMENTAL

Biological: JL15003Injection

Interventions

JL15003Injection BIOLOGICAL

Intratumoral or intracavitary administration of JL15003 Injection as needed

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 of age;
• \. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions ( \<=3 cm on contrast-enhanced MRI prior to JL15003 administration);
• \. Histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification;
• \. Refractory or relapsed following standard-of-care therapy or intolerance to standard therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide);
• \. Tolerable to intratumoral/intracavitary Ommaya reservoir catheter implantation;
• \. Karnofsky Performance Status (KPS) \>=70 and expected survival time \>= 3 months;
• \. 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;
• \. Able to undergo brain MRI with and without contrast;
• \. 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;
• \. Subjects voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.

You may not qualify if:

• \. Subjects who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;
• \. Patients with life-threatening cerebral hernia syndrome as determined by the investigator;
• \. 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;
• \. Patients with known history of agammaglobulinemia;
• \. Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease; Subjects with diffuse subependymal disease;
• \. 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;
• \. Patients with a 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);

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Huashan Hospital, Shanghai Medical College, Fudan University & Beijing TianTan Hospital,Capital Medical University

Shanghai, China

RECRUITING

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

Central Study Contacts

Hongwei Liu

CONTACT

+86 188 1466 8239; hongwei.liu@jechobio.com

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 16, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)