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

Sponsor
ZSky Biotech Inc
Study ID
NCT07365280
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 — BIOLOGICAL
    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.
  • Temozolomide (TMZ) — DRUG
    Patients receive standard adjuvant temozolomide chemotherapy alone

Study Details

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.

Key Dates

First listed
Jan 26, 2026
Start date
Jan 9, 2026
Status verified
Dec 2025
Primary completion
Dec 24, 2028
Completion
Dec 24, 2028

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Personalized dendritic cell vaccine ZSNneo-DC1.1 in combination with temozolomide.
  • Active Comparator: Control
    Standard adjuvant temozolomide chemotherapy alone

Primary Outcome Measure

PFS [ Time Frame: From randomization until disease progression or death, whichever occurs first，assessed up to 24 months ]

Central Contacts

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