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Tests treatment safety and results for Glioma
Official title Clinical Study for the Safety and Therapeutic Efficacy of the AI-QMMM Designed TamavaqTM Personalised Vaccine in Patients With Newly Diagnosed Glioma.
ClinicalTrials.gov ID: NCT07077616
What this study is testing
What is Biological: personalized vaccine Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced;?
Biological: personalized vaccine Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for glioma.
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
- Gliomas are a heterogeneous group of tumors arising from glial cells in the central nervous system and are associated with poor prognosis and significant morbidity. The most aggressive form, glioblastoma multiforme (GBM), remains particularly challenging to treat, often exhibiting resistance to conventional therapies such as chemotherapy and radiation.
- Phase 1: an early, usually small safety study
- Time commitment: about 7 weeks
- Which group you join is decided by chance.
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
- 1\. \ \ Age\ \ :
- Patients must be aged 18 years or older.
- signed inform consent;
- patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;
- patients' tumor tissue should have a high mutation load(\>10 TMB); be genetically unstable; at least have 10 neoantigens;
You likely can't join if
- \ \ Previous Treatments\ \ :
- Patients who have received prior treatment with immune checkpoint inhibitors, other cancer vaccines, or experimental immunotherapies that may...
- Patients with active autoimmune diseases or chronic inflammatory conditions requiring systemic treatment (e.g., rheumatoid arthritis, lupus, multiple...
- Pregnant or breastfeeding women, as the effects of the vaccine on fetal development or breastfeeding infants are not yet established. 4\. \ \ Other...
- Patients with any other malignancy within the past 5 years, except for non-melanoma skin cancer or localized prostate cancer that is not currently...
- Patients with uncontrolled medical conditions, including but not limited to:
See the full eligibility criteria
- 1\. \ \ Age\ \ :
- Patients must be aged 18 years or older.
- signed inform consent;
- patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;
- patients' tumor tissue should have a high mutation load(\>10 TMB); be genetically unstable; at least have 10 neoantigens;
- should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;
- at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy;
- have not received any immunotherapy;
- at least have one measurable lesion;
- KPS \>60;
- estimated survival \> 3 months
- patients should have adequate organ and bone marrow function; 2. \ \ Diagnosis\ \ :
- Histologically confirmed diagnosis of glioma, including:
- Glioblastoma multiforme (GBM, WHO grade IV)
- Anaplastic astrocytoma (WHO grade III)
- Diffuse astrocytoma (WHO grade II)
- Other gliomas (e.g., oligodendroglioma, mixed glioma) confirmed by pathology. 3\. \ \ Measurable Disease\ \ :
- Presence of measurable disease, defined as at least one tumor lesion that can be accurately assessed by imaging techniques (e.g., MRI) according to RECIST criteria. 4\. \ \ Performance Status\ \ :
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating that patients are fully active, restricted in physically strenuous activity, or unable to work but able to care for themselves. 5\. \ \...
- Laboratory results must indicate adequate organ function, including:
- Hematological parameters: Hemoglobin ≥ 9 g/dL, white blood cell count ≥ 3,000 cells/mm³, platelet count ≥ 100,000 cells/mm³.
- Liver function tests: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2.5 times the upper limit of normal (ULN) (or ≤ 5 times the ULN if there is liver involvement).
- Renal function: Serum creatinine ≤ 1.5 times the ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min. 6\. \ \ Informed Consent\ \ :
- Provision of written informed consent by the patient or their legally authorized representative, indicating understanding of the study procedures, potential risks, and benefits. 7\. \ \ No Prior Treatment with Certain...
- Patients must not have received prior treatment with immune checkpoint inhibitors or other experimental immunotherapies that may interfere with the study outcomes. 8\. \ \ Ability to Comply with Study Procedures\ \ :
- Patients must be able to comply with all study procedures, including follow-up visits and assessments, as determined by the investigator. 9\. \ \ No Significant Cognitive Impairment\ \ :
- Patients must not have significant cognitive impairment or psychiatric disorders that would compromise their ability to provide informed consent or adhere to the study protocol. These are designed to ensure that the...
- \ \ Previous Treatments\ \ :
- Patients who have received prior treatment with immune checkpoint inhibitors, other cancer vaccines, or experimental immunotherapies that may interfere with the study outcomes. 2\. \ \ Active Autoimmune Diseases\ \ :
- Patients with active autoimmune diseases or chronic inflammatory conditions requiring systemic treatment (e.g., rheumatoid arthritis, lupus, multiple sclerosis). 3\. \ \ Pregnancy or Breastfeeding\ \ :
- Pregnant or breastfeeding women, as the effects of the vaccine on fetal development or breastfeeding infants are not yet established. 4\. \ \ Other Malignancies\ \ :
- Patients with any other malignancy within the past 5 years, except for non-melanoma skin cancer or localized prostate cancer that is not currently active. 5\. \ \ Uncontrolled Medical Conditions\ \ :
- Patients with uncontrolled medical conditions, including but not limited to:
- Cardiovascular disease (e.g., recent myocardial infarction, severe heart failure).
- Uncontrolled infections (e.g., HIV, active hepatitis B or C).
- Severe chronic lung disease. 6\. \ \ Significant Cognitive Impairment\ \ :
- Patients with significant cognitive impairment or psychiatric disorders that would limit their ability to provide informed consent or comply with study procedures. 7\. \ \ Severe Allergies\ \ :
- Patients with known hypersensitivity or severe allergic reactions to any component of the vaccine formulation or adjuvants used in the study. 8\. \ \ Concurrent Participation in Other Clinical Trials\ \ :
- Patients currently participating in other clinical trials involving investigational drugs or therapies that may interfere with the study outcomes. 9\. \ \ History of Organ Transplant\ \ :
- Patients who have received an organ transplant that requires ongoing immunosuppressive therapy. 10\. \ \ Severe Comorbidities\ \ :
- Patients with severe comorbid conditions that, in the opinion of the investigator, may compromise the safety of the patient or interfere with the assessment of the study endpoints. -
The study team makes the final eligibility decision.
Where it's taking place
- Thessaloniki, Greece
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 study runs about 7 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Thessaloniki, Greece. 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.