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New treatment option for High-grade Gliomas
Official title A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas
ClinicalTrials.gov ID: NCT06660056
What this study is testing
What is A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Recurrent or Progressive Gliomas of the Brain?
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Recurrent or Progressive Gliomas of the Brain is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for high-grade gliomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be eligible for participation in this study, individuals must meet the following criteria:
- people 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...
- 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...
You likely can't join if
- 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...
- Females of childbearing age who have a positive pregnancy test or are lactating.
- Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
See the full eligibility criteria
Who can join
- To be eligible for participation in this study, individuals must meet the following criteria:
- people 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...
- At least 1 intracranial measurable lesion according to RANO criteria (well-defined enhancing lesion detected on MRI, diameter \>10 mm).
- Patient's willingness to undergo surgical maneuvers related to placement of the Ommaya capsule.
- Karnofsky functional status ≥ 60.
- Be expected to survive for at least 3 months.
- No serious hematologic (no adjuncts such as EPO, G-CSF, or GM-CSF within 14 days prior to the first dose and no blood transfusions for at least 7 days), hepatic, or renal function abnormalities consistent with the...
What rules you out
- 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...
- Females of childbearing age who have a positive pregnancy test or are lactating.
- Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
- Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.
- Patients who have previously received lysosomal virus, stem cell, or gene therapy products.
- Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for those who did not receive the test drug).
- Those who have undergone antitumor therapy, including radiation therapy (except palliative radiotherapy), chemotherapy, biotherapy, endocrine therapy, and immunotherapy within 28 days prior to the first administration...
- Individuals who have undergone surgery or treatment therapy (excluding tumor biopsy, puncture, Ommaya capsule etc.).
- Individuals who have been treated with systemic corticosteroids (at a dose equivalent to \>10 mg dexamethasone /day) or other immunosuppressive medications within 28 days prior to the first dose, or who are currently...
- short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergic diseases is permitted;
- the use of topical topical or inhaled glucocorticoids is permitted;.
- A history of severe cardiovascular disease, including but not limited to:
- A history of severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree II-III AV block requiring clinical intervention;
- Acute coronary syndrome, congestive heart failure, aortic coarctation, stroke, or other grade or greater cardiovascular event within 6 months prior to the first dose;
- New York Heart Association (NYHA) \> Class II heart failure or left ventricular ejection fraction (LVEF) \ 450msec (men) and \>470msec (women) using the Fridericia formula; any factor that increases the risk of QTc...
- Clinically uncontrolled hypertension (blood pressure uncontrolled at \< 160 mmHg systolic and \< 100 mmHg diastolic after standard antihypertensive treatment).
- Recent Grade 3 or greater bleeding event within 6 months prior to the first use of study drug, or who have current \> Grade 2 bleeding, or hemangioma/vascular malformation, or tumor stroke, tumor invasion of a blood...
- Those with a history of severe hemoptysis.
- Patients with uncontrolled or severe diseases, including but not limited to persistent or active infections requiring antibiotic therapy.
- .people with active or prior history of autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple...
- type 1 diabetes mellitus that is stabilized on a fixed dose of insulin;
- autoimmune hypothyroidism or Hashimoto's thyroiditis that requires only hormone replacement therapy；
- Individuals with a history of exfoliative skin conditions requiring systemic therapy (e.g., eczema or atopic dermatitis) are also excluded.
- Persons who are positive for human immunodeficiency virus (HIV) antibodies.
- Persons who have active hepatitis B (HBV)/hepatitis C (HCV) infection are not eligible for enrollment. However, people with a previous history of hepatitis C but negative HCV RNA at screening may be enrolled, and those...
- Patients with documented psychiatric illnesses or disorders that may impact adherence to the trial protocol.
- Patients with malignant tumors that may require antitumor therapy other than the investigational drug GC001.
- Patients who, as determined by the investigator, are unsuitable for participation in the study. \-
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.