Brain cancer vaccine targets survivin protein to boost immune attack
NCT ID NCT07715097
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This phase II trial tests whether a personalized dendritic cell vaccine targeting the Survivin protein can improve survival in people with newly diagnosed glioblastoma, an aggressive brain cancer. Participants receive the vaccine alongside standard chemotherapy after surgery. The study aims to see if this immune-boosting approach helps control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a personalized dendritic cell vaccine that targets the Survivin protein, given alongside standard chemotherapy
- What this could lead to
- If successful, this approach could extend survival for people with glioblastoma, a brain cancer with few effective treatments.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply broadly. The vaccine may cause immune-related side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age between 18 (inclusive) and 70 (inclusive) years old, with no gender restriction. * Pathologically confirmed newly diagnosed WHO grade 4 glioblastoma multiforme (GBM). * Positive for Survivin expression by immunohistochemistry. * Extent of tumor resection meets grade 1 or 2 of the RANO surgical resection classification (definition ofRANO classification is provided in Appendix 1). * Karnofsky Performance Status (KPS) score ≥ 70 prior to enrollment. * Agree not to receive any other glioblastoma-directed therapies during the trial, except for radiotherapy,temozolomide, and targeted Survivin DC cell injection. * Female subjects must have a negative pregnancy test; both male and female subjects agree to use non-pharmacological contraceptive measures during the trial period. * Adequate basic hematological function: a) White blood cell count ≥ 2.0 × 10⁹/L b) Absolute neutrophilcount ≥ 1.5 × 10⁹/L c) Lymphocyte count ≥ 0.5 × 10⁹/L d) Platelet count ≥ 100 × 10⁹/L e) Hemoglobin ≥ 9.0g/dL (90 g/L). * Expected survival ≥ 14 weeks.Expected survival ≥ 14 weeks. * Sufficient venous access for mononuclear cell apheresis and no other contraindications toleukapheresis. * Voluntary participation in the clinical study; subject or legal guardian fully understands the study,provides informed consent, and is willing to comply with and complete all study procedures. Exclusion Criteria: * History of other malignancies or concurrent other malignancies (except adequately treated carcinoma insitu of the cervix, basal cell or squamous cell skin cancer, locally confined prostate cancer after radicalresection, thyroid cancer, and ductal carcinoma in situ after radical resection). * Contrast-enhanced MRI within 7 days after tumor surgery shows a residual lesion diameter \> 1 cmcompared with preoperative status. * Use of 5-aminolevulinic acid dye during surgery. * Failure to complete at least two-thirds of the prescribed total dose of conformal radiotherapy over theroutine 6-week period, or failure to complete a total of 5 weeks of concurrent temozolomide chemotherapyas scheduled. * Interval between the start of 6-week concurrent chemoradiotherapy and the completion of surgeryexceeds 50 days. * Disease progression documented after concurrent chemoradiotherapy and prior to study treatmentinitiation. * Hypersensitivity to any active ingredient or excipient of the investigational product (including sodiumchloride injection containing 10% human albumin), or history of allergy to penicillin or ampicillin. * Pregnant or lactating female subjects. * Administration of corticosteroids within 7 days prior to apheresis of peripheral blood mononuclear cells. * Expected daily dose of corticosteroids (e.g., dexamethasone) exceeding 2 mg/day, or single doseexceeding 10 mg, within 30 days before the first dose and during the treatment period. * Requirement for immunosuppressive agents during the study period. * Receipt of immune cell therapy within 6 months prior to screening. * Use of any anti-T cell therapy within 4 weeks prior to screening. * Acute infection or unexplained fever: active viral, bacterial, or fungal infection requiring specific therapy(e.g., antibiotics); unexplained fever with body temperature \> 38°C. * Positive HIV antibody, positive syphilis antibody, positive HBsAg, positive HBcAb, positive or elevatedperipheral blood HBV DNA titer above upper limit of normal (ULN), positive anti-HCV antibody or positiveHCV RNA. * Presence of severe or unstable cardiac, pulmonary, hepatic, renal, or coagulation disorders, including:a)Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;b) Acute myocardialinfarction within 6 months;c) Exacerbation of chronic obstructive pulmonary disease or other respiratorydisorders requiring hospitalization;d) SGOT (AST) \> 3 × ULN, SGPT (ALT) \> 3 × ULN, total bilirubin \> 1.5 ×ULN;e) Serum creatinine \> 1.5 × ULN;f) Coagulation parameters: international normalized ratio (INR) \> 1.5 ×ULN; activated partial thromboplastin time (APTT) \> 1.5 × ULN;g) Severe psychiatric disorder, poorcompliance, or lack of legal capacity to consent;h) Severe neurological disease or neurological deficit,diffuse leptomeningeal disease, or concurrent neurodegenerative disease;i) Immunodeficiency orautoimmune disease, including systemic lupus erythematosus, polymyositis, insulin-dependent diabetesmellitus, etc. * History of organ transplantation. * Inability or unwillingness to undergo magnetic resonance imaging (MRI) scans during the study. * Any other circumstances in which the investigator deems the subject unsuitable for enrollment in thisclinical trial (including but not limited to poor compliance, drug abuse, etc.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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