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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age \>= 18 years of age;

• 2\. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions ( \<=3 cm on contrast-enhanced MRI prior to JL15003 administration);

• 3\. Histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification;

• 4\. Refractory or relapsed following standard-of-care therapy or intolerance to standard therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide);

• 5\. Tolerable to intratumoral/intracavitary Ommaya reservoir catheter implantation;

• 6\. Karnofsky Performance Status (KPS) \>=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.

Locations
Other Locations
China
Huashan Hospital, Shanghai Medical College, Fudan University & Beijing TianTan Hospital,Capital Medical University
RECRUITING
Shanghai
Contact Information
Primary
Hongwei Liu
hongwei.liu@jechobio.com
+86 188 1466 8239
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2030-04
Participants
Target number of participants: 40
Treatments
Experimental: administration of JL15003 Injection
Sponsors
Leads: Jecho Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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