Brain cancer vaccine shows promise in early trial
NCT ID NCT04968366
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a personalized vaccine made from a patient's own immune cells (dendritic cells) combined with standard chemotherapy (temozolomide) for adults with newly diagnosed glioblastoma, an aggressive brain cancer. Eleven patients who had most of their tumor removed by surgery received the vaccine and chemo to see if it was safe and could boost the immune system against the cancer. The goal was to control the disease, not cure it, as ongoing treatment is typically needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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11 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 75 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: 1. Age from 18 to 75 years (including 18 and 75 years old); 2. Newly-diagnosed glioblastoma confirmed by histopathological exams; 3. IDH1- and IDH2-wild-type gliomas; 4. Extent of resection of enhancing lesions \> 90%; 5. Karnofsky Performance Score(KPS) ≥ 60%; 6. Adequate organ functions: The absolute value of white blood cells ≥ 2.5×10 9/L; Hemoglobin levels\> 100 g/L; Platelet counts \> 100×109/L; Levels of Alanine aminotransferase, aspartate aminotransferase \<2.5 x ULN; Serum creatinine levels \<1.5 x ULN. Exclusion Criteria: 1. Subjects with any other active malignancy; 2. Subjects received the placement of Carmustine implants within 6 months before the inclusion; 3. Subjects with active HBC, HCV or HIV infection; 4. Subjects with grade 2 -3 hypertension or uncontrolled hypertension; 5. Subjects with severe cardio- or cerebro- vascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.; 6. Subjects with uncontrolled autoimmune diseases such as hemolytic anemia, psoriasis and rheumatoid arthritis, etc.; 7. Subjects with severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes; 8. Subjects receiving immunosuppressants after organ transplantation; 9. Within four weeks before the DC vaccinations, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid); 10. Subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment; receiving ongoing anticoagulant therapy; 11. Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment; 12. Within the 14 days before enrollment, subjects with active infections or uncontrolled infections that require systemic antibiotic treatment (except for simple urinary tract infections or upper respiratory tract infections); 13. Subjects who have received other vaccine therapies or gene-modified cell therapy before enrollment; 14. Subjects with number of the predicted neoantigen peptides less than 5; 15. Subjects with other conditions that would interfere trial participation at the investigator's discretion; 16. Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures; 17. Subjects who participated or are participating in other clinical trials within 4 weeks before enrollment.
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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.
Contacts and locations
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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