NCT07365280

Neoantigen-Pulsed Autologous Dendritic Cell Vaccine Combined With Temozolomide for Newly Diagnosed Glioblastoma

An Open-Label, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 in Combination With Temozolomide as Adjuvant Therapy in Patients With Newly Diagnosed Glioblastoma After Surgery and Concurrent Chemoradiotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: ZSky Biotech Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized Phase II clinical study designed to evaluate the efficacy and safety of a personalized dendritic cell (DC) vaccine, ZSNeo-DC1.1, in combination with temozolomide (TMZ) as adjuvant therapy in patients with newly diagnosed glioblastoma (GBM). Eligible patients with histologically confirmed, IDH1/IDH2 wild-type newly diagnosed glioblastoma who have undergone tumor debulking surgery followed by standard concurrent chemoradiotherapy will be enrolled. After confirmation of tumor neoantigens and eligibility, patients will be randomized in a 1:1 ratio to receive either ZSNeo-DC1.1 in combination with TMZ or TMZ alone. The primary objective is to evaluate progression-free survival (PFS) as assessed by an Independent Radiological Review Committee (IRRC) according to RANO 2.0 criteria. Secondary objectives include overall survival (OS), survival rates, tumor response outcomes, and safety. Exploratory objectives include assessment of antigen-specific T-cell immune responses induced by ZSNeo-DC1.1.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	Personalized Dendritic Cell Vaccine ZSNeo-DC1.1	Patients receive six subcutaneous injections of ZSNeo-DC1.1 during adjuvant temozolomide chemotherapy. ZSNeo-DC1.1 is administered at a fixed dose of 1 × 10⁷ cells per injection according to the assigned immunization schedule. Temozolomide is administered as per protocol.
DRUG	Temozolomide (TMZ)	Patients receive standard adjuvant temozolomide chemotherapy alone

Timeline

• Start date: 2026-01-09
• Primary completion: 2028-12-24
• Completion: 2028-12-24
• First posted: 2026-01-26
• Last updated: 2026-01-26