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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJecho Biopharmaceuticals Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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);

Disqualifiers

1. Subjects who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;

2. Patients with life-threatening cerebral hernia syndrome as determined by the investigator;

(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;

Trial design

Treatments tested in this trial

  • JL15003Injection

Treatment groups

40 Participants
are divided into 1 treatment group