A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGONGCHU Biotechnology Co., Ltd

About this trial

A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Recurrent or Progressive Gliomas .

Eligibility criteria

Qualifiers

Subjects must be able to comprehend and voluntarily sign written informed consent, which includes requirements related to study sample collection.

Able to communicate with researchers; Understand and comply with the requirements of the study; Voluntary and able to complete study procedures and follow-up examinations.

Be male or female patients aged 18 (including those with borderline age values).

Patients with recurrent or progressive high-grade gliomas (WHO grade III-IV) that have been histopathologically or molecularly diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).

Disqualifiers

Inability to perform an MRI for any reason.

focal point under the curtain.

Prior history of encephalitis, multiple sclerosis, or other central nervous system infection (unless resolved).

Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.

Trial design

Treatments tested in this trial

  • A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Recurrent or Progressive Gliomas of the Brain

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators