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

NCT07715097 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-20

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Beijing Tricision Biotherapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2029-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715097 on ClinicalTrials.gov