Actively Recruiting
A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas
Led by GONGCHU Biotechnology Co., Ltd · Updated on 2025-03-13
35
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official 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 and follow-up
- Male or female aged 18 years or older
- Diagnosed with recurrent or progressive high-grade gliomas (WHO grade III-IV) with no effective standard treatment
- Have at least one measurable intracranial lesion larger than 10 mm on MRI
- Willing to undergo surgical placement of an Ommaya capsule
- Karnofsky performance status of 60 or greater
- Expected survival of at least 3 months
- No serious hematologic, hepatic, or renal function abnormalities based on specified lab 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 for any reason
- History of encephalitis, multiple sclerosis, or other CNS infection unless resolved
- Previous diagnosis of another malignancy within 5 years except low-risk cancers
- Females who are pregnant or lactating
- Allergies to similar products or excipients
- History of severe systemic reaction to smallpox vaccination
- Previous treatment with lysosomal virus, stem cell, or gene therapy products
- Participation in other drug clinical trials or investigational drugs within 28 days prior
- Antitumor therapy including radiation (except palliative), chemotherapy, biotherapy, endocrine or immunotherapy within 28 days prior
- Recent surgery or interventional therapy except biopsy or Ommaya capsule placement
- Recent use of systemic corticosteroids or immunosuppressants within 28 days, with some exceptions
- Severe cardiovascular disease or uncontrolled hypertension
- Recent significant bleeding events or risk factors for bleeding
- History of severe hemoptysis
- Uncontrolled or severe infections
- Active or history of autoimmune diseases with potential recurrence or high risk
- Positive for HIV antibodies
- Active hepatitis B or C infection, with some exceptions based on viral load
- Psychiatric illness impacting adherence
- Malignancies requiring antitumor therapies other than GC001
- Any condition making the patient unsuitable for study participation as judged by investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
L
li wenbin, Professor
CONTACT
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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