Actively Recruiting
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)
Led by Jecho Biopharmaceuticals Co., Ltd. · Updated on 2026-03-30
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).
CONDITIONS
Official Title
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histopathologic or radiological confirmation of recurrent supratentorial glioblastoma multiforme with measurable lesions 3 cm or smaller on MRI prior to JL15003 administration
- Histopathology consistent with 2021 WHO glioblastoma classification
- Refractory or relapsed after standard therapy including surgery, radiotherapy, and temozolomide
- Able to tolerate intratumoral or intracavitary Ommaya reservoir catheter implantation
- Karnofsky Performance Status 70 or higher with expected survival time of at least 3 months
- Received trivalent inactivated poliovirus vaccine booster 1 week to 6 months before study drug administration with a neutralizing antibody titer of at least 1:8
- Able to undergo brain MRI with and without contrast
- Participants and their partners agree to effective non-pharmacological contraception from screening until 90 days after observation period
- Voluntarily willing to participate, sign informed consent, comply with study procedures, and cooperate with follow-up
You will not qualify if you...
- Allergy to any component of the investigational drug, contrast agent Maganweixian, or albumin
- Life-threatening cerebral hernia syndrome
- Active infection requiring intravenous treatment or unexplained fever above 99.5 F/37.5 C lasting more than one week
- Known immunodeficiency, including HIV or history of organ transplantation
- Severe heart disease (NYHA Class 3 or 4)
- History of recent vascular diseases within 6 months
- Uncontrolled hypertension despite medication
- Active thrombosis, bleeding, or high risk of bleeding conditions
- Active autoimmune disease requiring immunomodulatory therapy within 3 months
- History of agammaglobulinemia
- Tumors in brainstem, cerebellum, spinal cord, leptomeningeal disease, diffuse subependymal disease
- Tumor invasion near ventricular wall or crossing midline
- History of neurological complications from poliovirus infection
- Worsening steroid myopathy
- Another active malignancy requiring treatment except certain skin or cervical cancers
- Recent antitumor therapy within 4 weeks or not recovered from related toxicities
- Radiation therapy within 12 weeks prior to study drug administration except for progressive disease outside radiation area
- Use of more than 5 mg dexamethasone or equivalent steroids within 2 weeks prior to study drug
- Abnormal lab tests including low hemoglobin, low platelets, low neutrophils, elevated creatinine, bilirubin, liver enzymes, or coagulation times
- Positive for syphilis or active hepatitis B or C infection
- Received vaccination within 4 weeks prior to study drug administration except certain vaccines
- Pregnancy or lactation or positive pregnancy test within 7 days prior to treatment
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital, Shanghai Medical College, Fudan University & Beijing TianTan Hospital,Capital Medical University
Shanghai, China
Actively Recruiting
Research Team
H
Hongwei Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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