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 .
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).
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.
Sequential
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Recurrent or Progressive Gliomas of the Brain
Biological/VaccineUse of Ommaya capsules
Evaluate the safety and tolerability of GC001
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs)，treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Maximal tolerable dose
During the DLT observation period, the number of cases with DLT is less than or equal to the maximum dose of 1/6 of the total number of cases, and six evaluable participants are required to determine MTD.
Anti-tumor activity of GC001: response assessment of neuro-oncology(RANO).
To evaluate the response assessment of neuro-oncology(RANO) as a measurement of tumor response and disease progression.
Anti-tumor activity of GC001: immunotherapy response assessment for neuro-oncology (iRANO).
To evaluate the immunotherapy response assessment for neuro-oncology (iRANO) as a measurement of tumor response and disease progression.
Evaluate the viral biological distribution and shedding of GC001
Viral biodistribution and shedding analysis for GC001 injection are performed based on the viral Biodistribution and shedding Analysis Set (BVSS). Biological collection samples include blood, urine, throat swabs, omaya cyst aqueous ,injection site and injection site dressing samples (for tumor injection at the percutaneous puncture site only),and determination of viral DNA copy number in the above samples.
Pharmacodynamic analysis of cytokine levels in the peripheral blood and omaya cyst aqueous.
To assess the levels of cytokines including IFN-γ, TNF-α, IL-5、 IL-6 and IL-10 in the peripheral blood andomaya cyst aqueous.
Pharmacodynamic analysis of PD-1 and lymphocyte in the peripheral blood and omaya cyst aqueous
To assess the ratio of PD-1 and lymphocyte in the peripheral blood and omaya cyst aqueous.
immunogenicity
Immunogenicity analysis will measure the concertation of antidody (anti-VV antibody (ADA) and neutralizing antibody (Nab) )in the peripheral blood.
Click on the lead sponsor to view all of their trials.
