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NOT YET RECRUITING
NCT07715097
PHASE2

Survivin-Targeted Dendritic Cell (DC) Cell Injection for Newly Diagnosed Glioblastoma

Sponsor: Beijing Tricision Biotherapeutics Inc

View on ClinicalTrials.gov

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.

Official title: A Phase II Clinical Trial of Survivin-Targeted Dendritic Cell (DC) Injection for the Treatment of Newly DiagnosedGlioblastoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09-30

Completion Date

2029-09-30

Last Updated

2026-07-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Survivin-targeted DC Cell Injection

The standard treatment regimen for glioblastoma (GBM) is postoperative combined chemoradiotherapy plus adjuvant chemotherapy. Concurrent radiotherapy with temozolomide (TMZ) at 75 mg/m² is administered for 6 weeks in total. After an interval of 4 weeks (28 days), patients proceed to multiple cycles of adjuvant TMZ chemotherapy. Each 28-day cycle consists of oral temozolomide 150-200 mg/m² daily for 5 consecutive days, followed by a 23-day drug holiday, and the regimen is repeated every 28 days. Survivin-targeted DC cell injection regimen The Survivin-targeted DC cell injection is administered on Day 9 (±1 day) after completion of the 6-week standard concurrent chemoradiotherapy. Administration routes include intradermal and intravenous injection. Dosing is performed on Day 0, Day 14 (±1 day) and Day 28 (±2 day), for a total of 3 administrations. The total specification of Survivin-targeted DC cell injection is 6 mL per dose. The dose is divided between intradermal and intravenous route