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

Sponsor
Beijing Tricision Biotherapeutics Inc
Study ID
NCT07715097
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Survivin-targeted DC Cell Injection — DRUG
    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

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Survivin-loaded dendritic cell injection

Primary Outcome Measure

Primary Outcome Measure:Overall Survival (OS) [ Time Frame: From the date of glioblastoma (GBM) surgery until death from any cause, assessed up to 36 months. ]

Central Contacts

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