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New treatment option for Glioma, High Grade
Official title A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma
ClinicalTrials.gov ID: NCT07306299
What this study is testing
What is Glioma-related multi-target mRNA vaccines?
Glioma-related multi-target mRNA vaccines is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for glioma, high grade.
Also referred to as mV002.
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
- This clinical trial is designed to evaluate the safety and efficacy of a universal mRNA vaccine targeting a panel of glioma-associated mutations in patients with recurrent or progressive high-grade glioma. The primary objectives are to address the following key questions: 1) Is the mRNA vaccine safe for this patient population?
- 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 16 and older
You may be able to join if
- Adequate compliance, ability to comprehend the clinical trial, and provision of written informed consent.
- Male or female, aged ≥16 years.
- Histologically or cytologically confirmed WHO Grade III or IV glioma harboring one or more of the following mutations: H3.3K27M, H3.1K27M, H3.3G34R...
- Recurrent or progressive high-grade glioma, defined as a CNS WHO Grade 3-4 glioma confirmed by post-surgical histopathology, with documented...
- Life expectancy ≥3 months.
You likely can't join if
- History of other malignancies within the past 5 years (except appropriately treated carcinoma in situ of the cervix or non-melanoma skin cancer).
- History of hypersensitivity to chemotherapy agents or radiosensitizers used for central nervous system or head and neck cancers.
- History of severe allergic reactions to vaccines or any components of the investigational product.
- Positive serology for:
- Human Immunodeficiency Virus (HIV) antibody
- Hepatitis C Virus (HCV) antibody with detectable HCV RNA
See the full eligibility criteria
- Adequate compliance, ability to comprehend the clinical trial, and provision of written informed consent.
- Male or female, aged ≥16 years.
- Histologically or cytologically confirmed WHO Grade III or IV glioma harboring one or more of the following mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAF V600E, PIK3CA H1047R, IDH1 R132H, or EGFRvIII.
- Recurrent or progressive high-grade glioma, defined as a CNS WHO Grade 3-4 glioma confirmed by post-surgical histopathology, with documented recurrence or progression per RANO criteria on MRI following standard therapy...
- Life expectancy ≥3 months.
- Karnofsky Performance Status (KPS) ≥50. For people with spinal cord lesions, functional deficits due to paralysis will not be considered in the KPS assessment.
- Absence of significant bone marrow, cardiac, pulmonary, or renal dysfunction, defined as:
- Hematologic (without transfusion or hematopoietic growth factor support within 14 days):
- Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹/L
- Platelet count (PLT) ≥100 × 10⁹/L
- Hemoglobin (HGB) ≥90 g/L
- Hepatic Function:
- Alanine Aminotransferase (ALT) ≤2.5 × Upper Limit of Normal (ULN)
- Aspartate Aminotransferase (AST) ≤2.5 × ULN
- Total Bilirubin (TBIL) ≤1.5 × ULN
- Renal Function: \ Serum creatinine ≤1.5 × ULN OR estimated creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula)
- Coagulation:
- Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN
- International Normalized Ratio (INR) ≤1.5 × ULN
- Other:
- Left Ventricular Ejection Fraction (LVEF) ≥50% without clinically significant pericardial effusion on echocardiogram
- No clinically significant electrocardiogram (ECG) abnormalities
- Baseline oxygen saturation \>92% on room air
- Adequate immune function, defined as receiving dexamethasone ≤2 mg/day within the 3 days prior to screening without severe lymphopenia.
- Negative pregnancy test for women of childbearing potential (WOCBP); non-pregnant and non-lactating females; both male and female participants must agree to use highly effective contraception and have no plan for...
- History of other malignancies within the past 5 years (except appropriately treated carcinoma in situ of the cervix or non-melanoma skin cancer).
- History of hypersensitivity to chemotherapy agents or radiosensitizers used for central nervous system or head and neck cancers.
- History of severe allergic reactions to vaccines or any components of the investigational product.
- Positive serology for:
- Human Immunodeficiency Virus (HIV) antibody
- Hepatitis C Virus (HCV) antibody with detectable HCV RNA
- Hepatitis B Surface Antigen (HBsAg) with HBV DNA ≥2000 IU/mL
- Treponema pallidum (TP) antibody with a positive confirmatory test (e.g., RPR/TPPA)
- Active, uncontrolled infection, active tuberculosis, or active immunosuppressive disease.
- Any concurrent non-malignant illness or psychiatric condition that would preclude safe protocol participation; uncontrolled cardiovascular disease (e.g., coronary artery disease, angina, myocardial infarction...
- Inability or unwillingness to provide informed consent or participate voluntarily.
- Concurrent participation in another treatment clinical trial or participation within 3 months prior to screening.
- Severe infection or signs/symptoms of active infection within 2 weeks prior to the first dose of the investigational product.
- Administration of a live-attenuated vaccine within 4 weeks prior to the first dose.
- History of solid organ or hematopoietic stem cell transplantation.
- Any other condition that, in the opinion of the investigator, would jeopardize the subject's safety or compliance with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.