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

NCT07365280 | Not Yet Recruiting Phase 2

• 1 other identifier: ZSKY2025-1005
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

DC; Personalized neoantigen-pulsed autologous dendritic cells vaccine

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival assessed by an Independent Radiological Review Committee according to RANO 2.0 criteria

  From randomization until disease progression or death, whichever occurs first，assessed up to 24 months

Secondary Outcomes (7)

• OS

  From randomization until death from any cause，assessed up to 36 months

• Overall Survival Rates

  12 months, 18 months, and 24 months

• Investigator-Assessed Progression-Free Survival

  From randomization until disease progression or death，assessed up to 24 months

• Disease Control Rate (DCR)

  During treatment period

• Best Overall Response (BOR)

  During treatment period

Study Arms (2)

Experimental

EXPERIMENTAL

Personalized dendritic cell vaccine ZSNneo-DC1.1 in combination with temozolomide.

Biological: Personalized Dendritic Cell Vaccine ZSNeo-DC1.1; Drug: Temozolomide (TMZ)

Control

ACTIVE COMPARATOR

Standard adjuvant temozolomide chemotherapy alone

Drug: Temozolomide (TMZ)

Interventions

Temozolomide (TMZ) DRUG

Patients receive standard adjuvant temozolomide chemotherapy alone

Control; Experimental

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.

Also known as: Temozolomide

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be eligible:
• Age 18 to 75 years, inclusive
• Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
• Molecular diagnosis of IDH1/IDH2 wild-type
• Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy
• Karnofsky Performance Status (KPS) score of 50 to 100
• Adequate hematologic, hepatic, renal, and coagulation function
• Availability of sufficient tumor tissue and blood samples for neoantigen identification
• Adequate venous access for PBMC collection
• Life expectancy greater than 3 months
• Willingness to use effective contraception during study treatment and for 3 months thereafter
• Ability to understand and willingness to sign written informed consent

You may not qualify if:

• Subjects meeting any of the following criteria are ineligible:
• Not suitable for standard temozolomide-based chemoradiotherapy
• Prior participation in another interventional clinical trial within 4 weeks before randomization
• Prior implantation of carmustine wafers within 6 months
• Known hypersensitivity to temozolomide or dacarbazine
• Active autoimmune disease or requirement for systemic immunosuppressive therapy
• Active infection including HIV, active hepatitis B or C, or syphilis
• Use of systemic immunosuppressive therapy within 30 days before randomization
• Uncontrolled cardiovascular, metabolic, or systemic disease
• Pregnancy or breastfeeding
• Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results

Sponsors & Collaborators

• ZSky Biotech Inc: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaomin Ma, M.M

CONTACT

+0518-82342973; xiaomin.ma@zskybio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 26, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): December 24, 2028
• Study Completion (Estimated): December 24, 2028
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share