Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After S… (NCT04968366) | Clinical Trial Compass
CompletedPhase 1
Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery
China11 participantsStarted 2021-07-30
Plain-language summary
This is a single-center, single-arm phase I study to determine the safety and preliminary efficacy of autologous dendritic cells (DCs) loaded with multiple tumor neoantigen peptides administered as a cancer-treatment vaccine to treat adult postoperative patients with newly-diagnosed glioblastoma, in combination with the standard-of-care Temozolomide (TMZ) chemotherapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age from 18 to 75 years (including 18 and 75 years old);
✓. Newly-diagnosed glioblastoma confirmed by histopathological exams;
✓. IDH1- and IDH2-wild-type gliomas;
✓. Extent of resection of enhancing lesions \> 90%;
✓. Karnofsky Performance Score(KPS) ≥ 60%;
✓. Adequate organ functions:
Exclusion criteria
✕. Subjects with any other active malignancy;
✕. Subjects received the placement of Carmustine implants within 6 months before the inclusion;
✕. Subjects with active HBC, HCV or HIV infection;
✕. Subjects with grade 2 -3 hypertension or uncontrolled hypertension;
✕. Subjects with severe cardio- or cerebro- vascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
✕. Subjects with uncontrolled autoimmune diseases such as hemolytic anemia, psoriasis and rheumatoid arthritis, etc.;
✕. Subjects with severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (AEs)
Timeframe: All the AEs were recorded from the first shot to 8 weeks after the last shot.