Survivin-Targeted Dendritic Cell (DC) Cell Injection for Newly Diagnosed Glioblastoma
30 participantsStarted 2026-09-30
Plain-language summary
The overall objective of this study is to preliminarily evaluate the efficacy and safety of Survivin-targeted DC Cell Injection in the postoperative treatment of newly diagnosed glioblastoma.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome Measure:Overall Survival (OS)
Timeframe: From the date of glioblastoma (GBM) surgery until death from any cause, assessed up to 36 months.