Actively Recruiting
A Phase I Study Evaluating Safety, Biodistribution, Immunogenicity, and Antitumor Activity of Oncolytic Vaccinia Virus GC001 in Patients With Recurrent or Progressive Gliomas
Led by GONGCHU Biotechnology Co., Ltd · Updated on 2025-03-13
35
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, distribution, shedding, immune response, and initial antitumor effects of an investigational oncolytic vaccinia virus called GC001 in patients with recurrent or progressive high-grade gliomas. This Phase I open-label study includes dose-escalation and dose-expansion phases to determine the best dose and assess early signs of effectiveness in patients whose tumors have returned or worsened after standard treatments. The trial involves seven dose groups ranging from 1x10^6 to 1x10^9 PFU of GC001 delivered by intratumoral injection using Ommaya capsules. Dose escalation follows a 3+3 design with an accelerated titration for the lowest doses and traditional escalation for higher doses. Following the dose-escalation phase, the recommended dose may be used to enroll additional patients in the dose-expansion phase to further evaluate safety and preliminary antitumor activity. Participants will be closely monitored for up to 28 days after injection for dose-limiting toxicities and safety. Researchers will assess tumor response using established neuro-oncology criteria over a follow-up period up to two years. Other evaluations include pharmacodynamics, immunogenicity, virus shedding, and biodistribution. Patients will undergo surgical procedures for capsule placement and have regular clinical and laboratory assessments throughout the study.
CONDITIONS
Brief Title
A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent including study sample collection
- Able to communicate with researchers and comply with study procedures
- Male or female patients aged 18 years or older
- Diagnosed with recurrent or progressive high-grade gliomas (WHO grade III-IV) confirmed histopathologically or molecularly
- Have at least one measurable intracranial lesion larger than 10 mm on MRI
- Willing to undergo surgery for placement of an Ommaya capsule
- Karnofsky performance status of 60 or higher
- Expected survival of at least 3 months
- No serious hematologic, liver, or kidney function abnormalities based on specified laboratory tests
- Use effective contraception during treatment and for 6 months after dosing if of childbearing potential
You will not qualify if you...
- Unable to undergo MRI
- Prior history of encephalitis, multiple sclerosis, or unresolved central nervous system infections
- Diagnosis of other malignancies within 5 years except for low-risk cancers
- Positive pregnancy test or lactating females of childbearing age
- Allergies to similar products or excipients
- Previous severe reactions to smallpox vaccination
- Prior lysosomal virus, stem cell, or gene therapy
- Use of investigational drugs or participation in other drug trials within 28 days prior to first dose
- Antitumor therapy including radiation, chemotherapy, or immunotherapy within 28 days prior to first dose
- Recent surgery or interventional therapy except tumor biopsy or Ommaya capsule placement
- Use of systemic corticosteroids over 10 mg/day dexamethasone or immunosuppressives within 28 days prior to first dose
- Severe cardiovascular disease or uncontrolled hypertension
- Recent serious bleeding events or conditions increasing bleeding risk
- Active or severe infections requiring antibiotics
- History or risk of autoimmune diseases except certain stable conditions
- Positive for HIV antibodies
- Active hepatitis B or C infections except controlled cases
- Psychiatric illnesses impacting trial adherence
- Other malignant tumors requiring treatment besides GC001
- Investigator determination of unsuitability for participation
- History of exfoliative skin conditions requiring systemic therapy
- Use of antiviral medications sensitive to poxviruses except short-term or topical/inhaled glucocorticoids permitted under limited conditions
- Female subjects with positive pregnancy or lactation
- Subjects with severe allergies or multiple drug allergies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days from GC001 injection
Participants receive intratumoral injections of the Oncolytic Vaccinia Virus GC001 using Ommaya capsules. Dose escalation is performed using a 3+3 design with doses ranging from 1×10^6 to 1×10^9 PFU. Safety and tolerability are monitored closely during this period.
Visits during the 28-day dose-limiting toxicity observation period following injection
Duration - Up to 2 years from GC001 injection
Participants are monitored for antitumor activity and immunogenicity, including response assessments using RANO and iRANO criteria.
Periodic visits for assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
M
Mo guoyu
L
li wenbin, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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