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

January 15, 2026 updated by: ZSky Biotech Inc

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all the following criteria to be eligible:

Inclusion Criteria

  1. Age 18 to 75 years, inclusive
  2. Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
  3. Molecular diagnosis of IDH1/IDH2 wild-type
  4. Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy
  5. Karnofsky Performance Status (KPS) score of 50 to 100
  6. Adequate hematologic, hepatic, renal, and coagulation function
  7. Availability of sufficient tumor tissue and blood samples for neoantigen identification
  8. Adequate venous access for PBMC collection
  9. Life expectancy greater than 3 months
  10. Willingness to use effective contraception during study treatment and for 3 months thereafter
  11. Ability to understand and willingness to sign written informed consent

Exclusion Criteria:

Exclusion Criteria:

Subjects meeting any of the following criteria are ineligible:

  1. Not suitable for standard temozolomide-based chemoradiotherapy
  2. Prior participation in another interventional clinical trial within 4 weeks before randomization
  3. Prior implantation of carmustine wafers within 6 months
  4. Known hypersensitivity to temozolomide or dacarbazine
  5. Active autoimmune disease or requirement for systemic immunosuppressive therapy
  6. Active infection including HIV, active hepatitis B or C, or syphilis
  7. Use of systemic immunosuppressive therapy within 30 days before randomization
  8. Uncontrolled cardiovascular, metabolic, or systemic disease
  9. Pregnancy or breastfeeding
  10. Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Personalized dendritic cell vaccine ZSNneo-DC1.1 in combination with temozolomide.
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.
Other Names:
  • Temozolomide
Drug: Temozolomide (TMZ)
Patients receive standard adjuvant temozolomide chemotherapy alone
Active Comparator: Control
Standard adjuvant temozolomide chemotherapy alone
Drug: Temozolomide (TMZ)
Patients receive standard adjuvant temozolomide chemotherapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From randomization until disease progression or death, whichever occurs first，assessed up to 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From randomization until death from any cause，assessed up to 36 months
From randomization until death from any cause
From randomization until death from any cause，assessed up to 36 months
Overall Survival Rates
Time Frame: 12 months, 18 months, and 24 months
12 months, 18 months, and 24 months
Investigator-Assessed Progression-Free Survival
Time Frame: From randomization until disease progression or death，assessed up to 24 months
From randomization until disease progression or death，assessed up to 24 months
Disease Control Rate (DCR)
Time Frame: During treatment period
During treatment period
Best Overall Response (BOR)
Time Frame: During treatment period
During treatment period
6. Clinical Benefit Rate (CBR)
Time Frame: During treatment period
During treatment period
Safety and Tolerability
Time Frame: From first dose until 30 days after last dose，assessed up to 24 months
Incidence and severity of adverse events and serious adverse events graded according to NCI CTCAE v5.0
From first dose until 30 days after last dose，assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZSky Biotech Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 9, 2026

Primary Completion (Estimated)

December 24, 2028

Study Completion (Estimated)

December 24, 2028

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSKY2025-1005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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