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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • JL15003Injection

    Biological/Vaccine

    Intratumoral or intracavitary administration of JL15003 Injection as needed

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: administration of JL15003 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

Overall survival (OS)

Time frame
Up to 15 years
2

12-month OS rate

Time frame
From the first administration to 12 months after the first administration
3

Objective response rate (ORR)

Time frame
Up to 12 months
4

Disease control rate (DCR)

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

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